Transcatheter Aortic Valve Replacement (TAVR)

January 14, 2026

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services (CMS)
Department of Health and Human Services
Attention: CAG-00430R2

Re: Public Comment on Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement, CAG-00430R2

Dear Ms. Baldwin:

The Alliance for Aging Research (“Alliance”) applauds CMS for reconsidering the TAVR NCD, and we strongly urge the agency to 1) remove CED and other outdated coverage requirements and 2) expand national coverage to all FDA-approved uses for the treatment of symptomatic and asymptomatic aortic stenosis (AS). The Alliance is the leading nonprofit organization dedicated to changing the narrative to achieve healthy aging and equitable access to care.

The CMS TAVR NCA is a pivotal opportunity for this Administration to balance a reduction in Medicare costs [1] with improved patient access to a preferred, less invasive treatment option—including shorter hospital stays and recovery times, better quality of life measures, and lower incidence of some major complications across all surgical risk levels.[2,3] The latest good news comes from the October 2024 results of the EARLY TAVR trial for those with clinically significant, asymptomatic severe AS, published in the New England Journal of Medicine [4], which found those who had TAVR had lower incidence of death, stroke, or unplanned hospitalization for cardiovascular outcomes compared with those who had routine clinical surveillance (i.e., “watchful waiting”). The FDA subsequently approved the use of TAVR in asymptomatic AS in May of 2025.

Unfortunately, the current TAVR NCD does not include Medicare coverage for the asymptomatic AS indication. This leaves beneficiaries with inconsistent coverage at the local level.

As CMS carefully considers the 14 years of extensive evidence on TAVR, we hope they confidently declare success by removing the CED and other coverage requirements from the NCD and expanding national coverage to all FDA-approved indications for AS treatment. Such a decision would not only align with the CMS Administrator’s goals to modernize and streamline Medicare utilization management, but it would also remove barriers to less invasive AS care for all beneficiaries, in all areas of the U.S.

TAVR has Been the Established Standard of Care Since 2017

An estimated 2.5 million people over the age of 75 have aortic stenosis, one of the most common types of heart valve disease.[5,6] Left untreated, it can progress rapidly and unpredictably to severe aortic stenosis, and it is estimated that 1 in 10 patients experiencing symptoms of severe aortic stenosis may die within five weeks.[7]

When the FDA first approved TAVR in 2011, it was an important advancement for older adults with severe aortic stenosis who needed an aortic valve replaced but were too ill or frail to withstand open-chest surgery. The American College of Cardiology and Society for Thoracic Surgeons sent a formal request to Medicare to initiate a TAVR NCD requiring CED, and co-led the introduction of the CMS-approved, TVT registry clinical study in 2012.[8]

TAVR for patients with symptomatic, severe aortic stenosis became the clinical standard of care in 2017 for high-risk, inoperable, and increasingly, intermediate-risk patients, supported by robust randomized trial data and reflected in professional society guidelines soon thereafter.[9,10] Despite this clear clinical consensus nearly 10 years ago, Medicare coverage for TAVR has remained subject to CED, creating a growing disconnect between specialty clinical guidelines and CMS policy.

This incongruence is starkly reflected in patient access. In 2019 the TVT Registry reported that 72,991 patients received TAVR.[11] That sounds like a high level of access, but a 2017 article in the American Heart Association Journal, Circulation: Cardiovascular Quality and Outcomes, suggests otherwise. The analysis estimates that the number of U.S. patients with severe symptomatic aortic stenosis eligible for TAVR at high-risk is 111,205; intermediate risk is 34,991; and low risk 89,736—a total of 235,932 eligible patients. Using those estimates, only 31% of those potentially eligible for TAVR have been treated with the procedure in the U.S.[12]

The Financial Tug-of-War Between Specialist Societies, Major Medical Centers, and Smaller/Rural Hospitals

For nearly 14 years, Medicare patients with AS have been stuck in the middle of a professional sea change in heart valve disease among thoracic surgeons and interventional cardiologists, as well as between major medical centers and smaller, community-based/rural hospitals. Medicare coverage for TAVR is entrenched in both the CED registry-based study requirements and procedural volume coverage criteria that have an outsized financial benefit to large, well-resourced medical centers and the organizations that manage these data systems.

There are two major financial incentives at play here. First, the American College of Cardiologists Foundation—and to a lesser degree the Society for Thoracic Surgeons—makes tens millions of dollars annually [13] off its TVT [14] and other registry products. When the Alliance inquired, the TVT Registry charged a one-time set-up fee ($25,000) and an annual participation fee ($10,000) per facility, which today totals 860 participating hospitals. The companies that make TAVR valves also pay the societies for registry data on their own products. Smaller, community based and rural hospitals often lack the infrastructure or financial ability to participate in the registries, or meet minimum procedural volume requirements, and therefore are unable to offer TAVR, stopping patients from receiving the treatment, or, more commonly, funneling them back to larger hospital systems which stand to profit from their business.

It is important to note that TVT registry sponsors appoint the advisors that decide on the health outcomes information collected; own the registry data; control who can access the data; and determine what types of analyses may be conducted using the data. CMS currently has no direct access to the registry data and no enforcement authority over whether or how the agency’s registry-related evidence questions are answered, let alone answered within a designated period. As a result, CEDs may drag out for a decade or more with no definitive end—leaving beneficiary access hanging in uncertainty.

Moreover, the TAVR Data Collection Form v3 form, available on the TVT Registry website [15], is onerous at 11 pages long and the registry has collected massive amounts of data on millions of patients, resulting in hundreds of published studies. The question is, what is the evidence threshold needed to end the TAVR CED? Specialty societies and many large hospitals argue in this NCA public comment that there is no threshold. That concerns us as patient advocates, and we hope CMS shares our concern.

The result is that beneficiaries are left navigating a system that is shaped less by clinical need than by institutional resources, administrative compliance, and professional turf.

14 Years of TAVR CED is Utilization Management Abuse

NCD with CED is a markedly restrictive coverage requirement. It is important to note that the Agency’s CED policy was not authorized by Congress—it was created and implemented by CMS starting in 2005 as a NCD requiring study participation. The CED “paradigm,” as coined by CMS, was first outlined in a 2006 regulatory guidance, and updated in 2014.

Initially, CED was utilized to accelerate access to medical devices, which have fewer clinical trial requirements in comparison to drugs and biologics. As time passed, CMS expanded its use of CED to other therapeutic types and diagnostics. Under CED, the Agency denies Medicare coverage for an FDA-approved item or service except when it is provided to beneficiaries within a population-limited clinical study, such as a CMS-approved clinical trial or data registry. Beneficiaries who are ineligible under the strict CED requirements, cannot access the clinical study sites, or are reluctant to be required to enroll in a clinical study to receive access are left without coverage. Once CMS places a treatment in CED, it is extraordinarily difficult for the coverage restriction to be lifted. An August 2022 systematic review of CED program history, published in The American Journal of Managed Care identified that, between 2005–2022, CMS issued a total of 27 NCDs requiring CED. Only four have been retired [16] by the Agency, which has taken an average of 8 years to do so.[17] Under its current paradigm, CMS has enabled 22 CEDs to continue in perpetuity, including several that have been ongoing for more than 15 years.[18]

Broadly, the Alliance is concerned about the implications that the continuation of a CED would have on Medicare beneficiaries’ ability to access TAVR. CED limits beneficiaries’ ability to obtain care outside narrowly defined parameters by requiring that beneficiaries participate in specific clinical trial registries and receive care at only designated setting by certain specialists. While the Medicare program is not supposed to consider cost when making coverage determinations, former HHS assistant secretary Dr. Richard Frank has characterized NCDs as “the most powerful coverage tool that Medicare has and have generally been reserved for Medicare services that are costly ...”. This quote serves as a peek behind the curtain of the fundamental flaw of CED: it uses the “need” for further evidence as a barrier to patient access.

This is especially true for beneficiaries in rural areas, who are unable to travel to study sites. Requiring beneficiaries to travel to designated study sites as a condition of coverage disproportionately harms rural communities by creating geographic and logistical barriers that many patients cannot realistically overcome. Rural beneficiaries often live hours from academic medical centers where CED studies are typically conducted, and long distances can be especially burdensome for older adults, people with disabilities, and those managing chronic or progressive conditions. These challenges are further compounded by limited access to reliable transportation, fewer local specialty providers, and higher out-of-pocket costs for travel and lodging. In 2019, a Morning Consult survey found that one in three rural adults and 36% of rural adults age 65+ find it difficult to access large urban-based hospitals. In 2019, a Morning Consult survey found that one in three rural adults and 36% of rural adults age 65+ find it difficult to access large urban-based hospitals. [19] These individuals reported that appointment availability, insurance coverage, travel distance and costs, and wait times are the top barriers to accessing large urban-based hospitals for treatment.

Legal Authority

Older adults meet with their health care providers, often alongside family caregivers, to discuss the benefits and risks of treatment, according to their diagnosis and needs. It is against federal law for CMS to interfere with clinical care. Section 1801 of the Medicare law states, “Nothing in this title shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.” [20] Section 1801 was included in the law to offset the criticism made by opponents of the proposal that Federal legislation would give Federal officials the opportunity and the right to interfere in the diagnosis and treatment of the individual. [21]

As is substantially noted in the Alliance’s 2023 report Façade of Evidence, CED is not mentioned in statute and was originally developed by CMS in a 2006 guidance. [22] Congress has not ratified CMS’ CED powers, or authorized CMS to conduct research studies into the effectiveness of medications or medical devices. In fact, Robert Charrow, former HHS General Counsel, previously issued an HHS Office of General Counsel Advisory Opinion explaining that CMS’ interpretation of its statutory authority to use CED as the basis for coverage of items and services is “unlawful […]” because CMS’s “broad reading of the term [support] is fundamentally inconsistent with” the legal definition of public health service support. [23]

Recommendations

Now, TAVR is being investigated for earlier intervention in moderate or even asymptomatic patients to determine if preventative treatment using TAVR can stop damage from progressing more broadly. Traditionally, these patients have been managed with a “watchful waiting” approach until symptoms develop—a technique that was used to avoid the risks and complications of a procedure before it was necessary to confront those risks. Now, growing evidence suggests that TAVR can be used as a tool to prevent heart damage before it can occur, allowing patients to experience better quality of life and long-term cardiac outcomes if the TAVR intervention is done earlier. Continuing to apply CED to established indications conflates emerging research needs with settled science, unnecessarily restricting access for beneficiaries who already meet long-standing clinical criteria. CMS should retire CED for prior indications.

Further, CMS should not impose CED for newer indications of TAVR, including use in asymptomatic patients, where the clinical evidence base is already clear and continuing to evolve through routine clinical practice. Randomized controlled trials and long-term follow-up data demonstrate the safety and effectiveness of TAVR across a broad range of patient risk profiles, and clinical guidelines have already incorporated these findings into standard care pathways. Additional conditional coverage requirements would not meaningfully improve the evidence base but would instead delay access to appropriate treatment and create unnecessary barriers to care. CMS should provide clear and consistent national coverage rather than rely on CED mechanisms that are no longer justified.

Lastly, CMS should avoid using gaps in evidence for patients with comorbid conditions as justification for coverage policies that further narrow access to TAVR for those with the greatest clinical need. Issuing a CED decision that adds new clinical study requirements, restrictive coverage conditions related to sites of care or specialist type, or burdensome data collection mandates, risks delaying or restricting access for patients with multiple or high-risk comorbidities. These populations are often underrepresented in studies but are among those most likely to rely on TAVR as a less invasive treatment option. The clinical evidence base already exists, and CED would only reduce the availability of these treatments for patients who need them most. Rather than enabling study of these populations, CED risks shrinking and distorting the very data CMS seeks to obtain.

Conclusion

CMS should move forward with a full NCD for TAVR without the use of CED for any indication. The existing clinical trial data, real-world evidence, and incorporation of TAVR into clinical guidelines together support broad and consistent coverage, and continued reliance on CED is no longer appropriate or necessary. The Alliance appreciates CMS’s consideration of these comments and stands ready to work with the agency as it evaluates this NCA. Please do not hesitate to contact Adina Lasser, Director of Public Policy and Government Relations, at alasser@agingresearch.org with any questions or requests for additional information.

Sincerely,

Susan Peschin, MHS
President and CEO
Alliance for Aging Research

Adina Lasser
Director of Public Policy and Government Relations
Alliance for Aging Research

[1] Baron, S.J., et al., Contemporary Costs Associated With Transcatheter Versus Surgical Aortic Valve Replacement in Medicare Beneficiaries. Circ Cardiovasc Interv, 2022. 15(3): p. e011295. https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.121.011295?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed.
[2] Lauck, S.B., et al., Temporal Changes in Mortality After Transcatheter and Surgical Aortic Valve Replacement: Retrospective Analysis of US Medicare Patients (2012-2019). J Am Heart Assoc, 2021. 10(20): p. e021748. https://www.ahajournals.org/doi/10.1161/JAHA.120.021748?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
[3] Columbia University Irving Medical Center, Department of Surgery. (2019, March 17). A breakthrough in heart valve surgery: More people can now benefit from TAVR procedure. Columbia Surgery. https://columbiasurgery.org/news/2019/03/17/breakthrough-heart-valve-surgery-more-people-can-now-benefit-tavr-procedure.
[4] Genereux, P., et al., Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med, 2024. https://www.nejm.org/doi/abs/10.1056/NEJMoa2405880.
[5] Osnabrugge RL, Mylotte D, Head SJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013;62(11):1002-1012.
[6] U.S. Census Bureau. S0101: AGE AND SEX – Census Bureau Table. Accessed May 20, 2025. https://data.census.gov/table/ACSST5Y2020.S0101?q=age&g=010XX00US&tid=ACSST5Y2020.S0101
[7] Malaisrie SC, McDonald E, Kruse J, et al. Mortality while waiting for aortic valve replacement. Ann Thorac Surg. 2014;98(5):1564-1571.
[8] https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id257.pdf.
[9] Cover Story: Fifteen Years of TAVR; Where Are We Now? Jul 20, 2017, Cardiology Magazine. https://www.acc.org/Latest-in-Cardiology/Articles/2017/07/19/15/42/Fifteen-Years-of-TAVR-Where-Are-We-Now#:~:text=%22The%20evolution%20of%20TAVR%20over,2.
[10] 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults With Aortic Stenosis: A Report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents, JACC, Volume 69, Number 10, 14 March 2017, Pages: 1313 – 1346. https://www.jacc.org/doi/10.1016/j.jacc.2016.12.006.
[11] STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement, Carroll, John D. et al. The Annals of Thoracic Surgery, Volume 111, Issue 2, 701 – 722.
[12] De Sciscio P, Brubert J, De Sciscio M, Serrani M, Stasiak J, Moggridge G. Quantifying the shift towards transcatheter aortic valve replacement in low-risk patients: a meta-analysis. Circ Cardiovasc Qual Outcomes. 2017;10:e003287. doi: 10.1161/CIRCOUTCOMES.116.003287. https://www.ahajournals.org/doi/full/10.1161/CIRCOUTCOMES.116.003287
[13] American College of Cardiology Foundation 2023 Form 990, on CANDID, page 2: https://app.candid.org/profile/6939018/american-college-of-cardiology-foundation-13-5641985?_gl=1*15ssw8m*_gcl_au*MjExMzg5MjUyMS4xNzY4MzQ3MDg4*_ga*Njg3MzUyNDguMTc2ODM0NzA4OA..*_ga_5W8PXYYGBX*czE3NjgzNDcwODckbzEkZzAkdDE3NjgzNDcwODckajYwJGwwJGgw&activeTab=7
[14] https://www.ncdr.com/WebNCDR/tvt/publicpage/data-collection.
[15] https://www.ncdr.com/WebNCDR/docs/default-source/tvt-public-page-documents/tvt-v3-0-tavr-11-18-2021sf.pdf?sfvrsn=96c0d69f_4.
[16] Smith, J. A., & Johnson, B. R. (1985). Reflections on the enactment of Medicare and Medicaid. Health Care Financ Rev. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4195078/.
[17] Centers for Medicare & Medicaid Services. (2014, November 20). Guidance for the Public, Industry, and CMS Staff: Coverage with Evidence Development ("CED Guidance"). CMS. https://www.cms.gov/medicare-coveragedatabase/view/medicarecoveragedocument.aspx?MCDId=27.
[18] Ibid.
[19] Ahead of an Imminent Medicare Coverage Decision, New Morning Consult Survey Shows More than 2/3 of Americans Support Broadening Access to a Less-Invasive Heart Valve Disease Treatment for Rural Communities: https://www.agingresearch.org/news/new-morning-consult-survey-broadening-access-to-a-less-invasive-heart-valve-disease-treatment/.
[20] https://www.ssa.gov/OP_Home/ssact/title18/1801.htm.
[21] Cohen WJ. Reflections on the enactment of Medicare and Medicaid. Health Care Financ Rev. 1985;Suppl(Suppl):3-11.
[22] Alliance for Aging Research. “Façade of Evidence.” 2023. https://www.agingresearch.org/wp-content/uploads/2023/02/Facade-of-Evidence-CED-2-13-2023.pdf
[23] Robert Charrow, Advisory Opinion 21-03 on Medicare Coverage with Evidence Development, U.S. Dep’t of Health & Human Servs. at 2 (Jan. 14, 2021) (emphasis added) (rescinded). While this advisory opinion has since been withdrawn, Charrow’s legal interpretation remains valid.

Less

Tamara Syrek Jensen, JD
Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services (CMS)
7500 Security Blvd
Baltimore, MD 21244

RE: National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2)

Dear Ms. Syrek Jensen:

As a cardiac surgeon and transcatheter valve operator with extensive experience in structural heart disease, I am writing to comment on the reconsideration of the TAVR National Coverage Determination (NCD).

**Expand Coverage to Asymptomatic Severe Aortic Stenosis**
The EARLY TAVR trial, published in the New England Journal of Medicine in 2024, demonstrated that in patients with asymptomatic severe aortic stenosis, early TAVR significantly reduced the composite of death, stroke, or unplanned cardiovascular hospitalization compared with guideline-recommended clinical surveillance. These findings fundamentally change the risk–benefit calculus, confirming that asymptomatic severe aortic stenosis is not a benign condition and that the risks of sudden cardiac death and rapid clinical deterioration are substantial. CMS should extend coverage to asymptomatic patients with severe aortic stenosis based on this new evidence.

**Reduce Barriers to Timely Treatment**
Severe symptomatic aortic stenosis remains undertreated despite the availability of two highly effective therapies. Wait-list mortality at one month (3.7%) equals 30-day operative mortality (3.9%)—except waiting confers no benefit. Each week of delay is associated with a 2% relative increase in one-year post-procedural mortality. Symptomatic severe AS should be treated as a semiurgent condition, not an elective one. The updated NCD should minimize logistical obstacles that delay care. Specifically, CMS should establish an automatic coverage transition pathway upon FDA approval for new indications, eliminating coverage gaps while maintaining registry participation for ongoing safety monitoring.

**Maintain Study Requirements for Off-Label Uses**
CMS should continue requiring that TAVR for uses not expressly listed as FDA-approved indications be performed within qualifying clinical studies. Registry and observational data indicate that patients treated with devices used within their labeled indications experience higher technical success and lower early mortality than those treated off-label, reflecting better procedural performance and patient selection. This framework protects patients while preserving pathways for evidence generation and innovation.

**Preserve the Multidisciplinary Heart Team**
TAVR stands as one of the most successful device launches in the history of cardiovascular medicine, with real-world outcomes that have often exceeded early expectations. The centerpiece of that success has been the multidisciplinary heart team, which transformed the culture of cardiovascular care from siloed competition to genuine collaboration between interventional cardiologists, cardiac surgeons, and imaging specialists. Dismantling this framework now would ignore these lessons and risk a reversion to a fragmented model of care that served patients poorly.

Those advocating for relaxation of team requirements identify a problem that does not meaningfully contribute to current access challenges. Far more consequential obstacles to timely TAVR access include delayed diagnosis, lack of clear processes to activate treatment once a diagnosis is made, burdensome pre-procedural prior authorization requirements, and geographic disparities in reimbursement, whereas multidisciplinary evaluation adds value rather than subtracting it. Surgeon and cardiology evaluation requirements should be maintained and supported as a model for other emerging structural heart therapies.

Thank you for considering these comments.

Sincerely,
Mark J. Russo, MD, MS
Professor of Surgery
Chief, Cardiac Surgery
Director, Structural Heart Disease
Rutgers-Robert Wood Johnson Medical School

Less

The success of transcatheter aortic valve replacement (TAVR) has been fundamentally driven by a true heart-team model, with medical cardiologists, interventional cardiologists, and cardiac surgeons collaborating before, during, and after procedures to deliver optimal patient-centered care. This longstanding culture of multidisciplinary partnership has enabled rapid growth, continuous refinement, and exceptional outcomes in TAVR at an unprecedented pace in cardiovascular medicine.

Maintaining cardiac surgeons as active TAVR implanters is essential to preserving this model and ensuring comprehensive, unbiased patient care. Patients deserve access to both interventional cardiologists and cardiac surgeons with procedural expertise in TAVR—not only for technical excellence during implantation, but for balanced counseling, management of procedural complexity and complications, and lifelong decision-making across the full spectrum of valvular heart disease as patient needs and therapeutic options evolve.

Less

The Honourable Mehmet Oz, MD
Office of the Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Dr. Oz,
We appreciate the opportunity to provide public comment on the Centers for Medicare and Medicaid Services’ reconsideration of the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (Section 20.32). TAVR is one of the most rigorously studied and clinically validated technologies in cardiovascular medicine and has become the standard of care for the treatment of severe aortic stenosis across surgical risk profiles.

Severe aortic stenosis is a progressive and lethal condition. Delays in definitive valve replacement are associated with increased mortality, heart failure hospitalizations, syncope, sudden cardiac death, and irreversible myocardial injury¹. Accordingly, coverage policies that introduce avoidable delays in care have direct and meaningful consequences for Medicare beneficiaries.

Since the original NCD was established under Coverage with Evidence Development in 2012 and updated in 2019, the evidence base supporting TAVR has matured substantially. Randomized controlled trials across all surgical risk strata have consistently demonstrated the safety and efficacy of TAVR. More recently, randomized trial data have also demonstrated benefit of early TAVR in patients with asymptomatic severe aortic stenosis ², supporting earlier intervention to prevent irreversible myocardial damage and adverse clinical events. These findings are reinforced by large national registries and long-term follow-up extending to 10 years, which demonstrate excellent durability and reproducible outcomes in contemporary practice^2-4.

We believe these robust data support a revision of the TAVR NCD to streamline workflow and improve patient access, and suggest the following modifications.

Modernization of procedural and care pathway requirements
While we support CMS’s commitment to patient safety and quality oversight, certain legacy requirements in the current NCD no longer reflect contemporary practice and now function as barriers to timely care.
First, mandating two operators for all cases introduces unnecessary logistical complexity that may delay treatment for a life-threatening condition. In high-volume programs, coordinating two operators can constrain procedural capacity and prolong time to intervention. Contemporary TAVR is a highly standardized catheter-based procedure that can be performed safely and effectively by a single experienced operator.
This requirement introduces logistical complexity that delays care for a life-threatening condition by limiting scheduling flexibility and procedural throughput. Importantly, extensive international experience demonstrates that TAVR can be performed safely in centers without on-site surgical backup. Registry studies from outside the United States show comparable outcomes with and without surgery on site, with no difference in procedural success, complications, or mortality ⁵. Moreover, the rate of conversion to open heart surgery in contemporary TAVR is low. These data indicate that mandatory co-operator requirements are not necessary to achieve the outcomes demonstrated in clinical trials.

Second, the current two-visit requirement for pre-procedural evaluation contributes to delays in care. Multiple mandatory visits, often separated by weeks due to scheduling and logistical constraints, are particularly problematic for patients with severe aortic stenosis, in whom delays are associated with adverse outcomes. Streamlining evaluation into a single visit when clinically appropriate would reduce time to treatment, improve patient experience, and decrease system inefficiencies without compromising safety or quality.

Removal of Coverage with Evidence Development registry requirements
Finally, we recommend removal of the Coverage with Evidence Development registry participation requirement. TAVR is among the most comprehensively studied interventions in cardiovascular medicine. The evidence gaps that justified CED in 2012 have been addressed through randomized trials, long-term durability data, and large-scale real-world registry analyses demonstrating outcomes comparable to pivotal trials across diverse patient populations. Valve durability through 10 years is now well established, and procedural outcomes in routine practice are highly reproducible. Continued mandatory registry participation imposes administrative burden without clear incremental benefit at this stage of technology maturity.

References
1. Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP, 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143:e35-e71. doi: 10.1161/CIR.0000000000000932
2. Genereux P, Schwartz A, Oldemeyer JB, Pibarot P, Cohen DJ, Blanke P, Lindman BR, Babaliaros V, Fearon WF, Daniels DV, et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2025;392:217-227. doi: 10.1056/NEJMoa2405880
3. Leon MB, Mack MJ, Pibarot P, Hahn RT, Thourani VH, Kodali SH, Genereux P, Kapadia SR, Cohen DJ, Pocock SJ, et al. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. N Engl J Med. 2025. doi: 10.1056/NEJMoa2509766
4. Thyregod HGH, Jorgensen TH, Ihlemann N, Steinbruchel DA, Nissen H, Kjeldsen BJ, Petursson P, De Backer O, Olsen PS, Sondergaard L. Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial. Eur Heart J. 2024;45:1116-1124. doi: 10.1093/eurheartj/ehae043
5. Eggebrecht H, Bestehorn M, Haude M, Schmermund A, Bestehorn K, Voigtlander T, Kuck KH, Mehta RH. Outcomes of transfemoral transcatheter aortic valve implantation at hospitals with and without on-site cardiac surgery department: insights from the prospective German aortic valve replacement quality assurance registry (AQUA) in 17 919 patients. Eur Heart J. 2016;37:2240-2248. doi: 10.1093/eurheartj/ehw190

Less

I am a cardiac surgeon and in short the answer is “no”, TAVR is not the solution for all. The real problem is that the trans-aortic valve replacement - TAVR (which is a misnomer, since the native valve is crushed and left in place, not replaced, and it should be called trans-aortic valve implantation - TAVI) is a fast growing business backed by the marketing of the manufacturing companies without having unbiased studies, it has no multiple or multi-center randomized clinical trials and no enough unbiased scientific data to support its indications in many cases. In the real world nowadays the so-called TARV is a one man show - the gatekeeper is diagnosing, grading and managing the aortic stenosis (AS) with no questioning and very little discussion of the benefits, risks, alternatives and consequences with the patients. There is a lot of data, publicly undisclosed and available only to the inquisitive mind, that clearly shows its inferiority to the surgical alternative, the surgical aortic valve replacement (SAVR), including the high percentage of patient-prosthesis mismatch (PPM) and the low durability of the implanted valve with the TAVR due to its accelerated deterioration due to the severe trauma caused to the valve during the implantation thru the small caliber catheters, ballooning and the persistence of the sick calcified native valve, drawbacks that are all avoided during the SAVR. Furthermore there is very little discussion with the patients about the consequences of the accelerated deterioration of the new implanted valve, unable to be extracted in the same way that it was placed, probably needing a second valve implanted (a valve-in-valve TAVI) or a surgical explantation - a very high surgical risk procedure that consist of replacing the whole aortic apparatus, including the implanted valve, the old crushed valve into the aortic root, replacing the ascending aorta, and reimplantation of the coronary arteries or perform multiple coronary bypasses as a consequence of a non functioning irreversible and non-able-to-fix TAVR/TAVI. So, why if the patient was not a candidate for surgery is becoming a “must have a high risk surgery” after a TAVR failure? Patients are going for interventional procedures with many things superficially discussed, however the “fear to surgery” strategic psychologic approach is always present during the TAVR presentations and speeches that I have attended. This is a very important and complex area of the cardiovascular system and the aortic stenosis is one of the most common heart conditions needing appropriate diagnosis, grading of the stenosis, and durable treatment, and a real heart-team discussion for a one-in-a-lifetime decisions, biological or mechanical, durability, anticoagulation, TAVR or SAVR, etc. At the beginning of the TAVR/TAVI era its proponents used to say that there were many patients declined by surgeons, they were too sick to operate due to the advanced disease. Obviously the TAVR operators didn’t say that the diagnosis was done late and their referral to the surgeons was very late. It appears that their box full of late referrals is getting empty and the show must go on with other patients, the patients that benefit the most with the SAVR, actually some are even saying that patients with moderate AS should have a TAVR. Why if they didn’t diagnosed and referred those patients with severe AS at operable stages for the more efficient, safe and durable SAVR, are going to be reliable now in continuing with the same method of one-man making the diagnosis and the same one-man making all the decisions? In my opinion, releasing the called TAVR for all asymptomatic patients with severe AS without revising the actual guidelines and indications by an unbiased committee, without having a serious independent analysis of the TAVR registry, and without having strong scientific evidence of benefits vs risks, is going to increase healthcare costs, may harm people with the wrong diagnosis and wrong timing, and it is going to increase hospital costs and mortality of the aortic valve surgery so badly that it may even disappear or has to be performed at very few super-subspecialized cardiovascular centers. Is that convenient for all or only for a few? Again, my advice is that we are not ready to take that step toward “TAVR for all”.

Less

January 14, 2026

Administrator Mehmet Oz
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-NCA Public Comments
7500 Security Boulevard
Baltimore, MD 21244
Public comment submitted via the CMS NCA Comment website

RE: Reopening of the Transcatheter Aortic Valve Replacement (TAVR) NCD 20.32 — CAG-00430R2

Dear Administrator Oz and CMS Coverage and Analysis Group:

Thank you for the opportunity to comment on the Medicare National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) initiated on December 15, 2025, in response to a formal reconsideration request submitted by Edwards Lifesciences on July 28, 2025.

I applaud CMS’ effort to expand patient access to TAVR therapy, but I have several reservations about elements of the NCA request and believe that a structural change to the NCD not included in the request letter is warranted. Below are the main points I would like to raise.

1. Revise from “TAVR for Aortic Stenosis” to TAVR for Aortic Disease
Medicare beneficiaries should not face delayed access to therapies that are safe, effective, and evidence based. TAVR studies approved by CMS to be conducted under Section B of NCD 20.32 have already been vetted by CMS to provide benefit to the Medicare population. Modernizing the NCD language to automatically transition coverage from Section B to full Section A coverage upon FDA approval would allow the policy to evolve without requiring reopening the NCD for each new indication – many of which are outside of the diagnosis of aortic stenosis. This would provide Medicare coverage for asymptomatic severe aortic stenosis now, and for valve-in-valve procedures for aortic disease, aortic regurgitation, and moderate aortic stenosis in the future, without further administrative burden. The new indications should still have to report into the nationally audited TVT Registry to accurately monitor quality and patient outcomes. This will reverse the unintended consequence of having to discontinue coverage once FDA approval is achieved and is in line with other Medicare NCDs.

2. Multidisciplinary Heart Team and Procedural Flexibility
The multidisciplinary heart team model has proven successful in TAVR and other cardiology programs. High-quality outcomes depend on dedicated expertise, focused training, and longitudinal experience among interventional cardiologists and cardiac surgeons who are actively engaged in structural heart care. This team-based approach should remain foundational to the NCD. To support access while preserving quality, greater flexibility in defining the intraprocedural operator team is warranted and should be aligned with existing NCDs for mitral and tricuspid transcatheter therapies. Allowing the local multidisciplinary heart team to determine whether procedures are supported by one interventional cardiologist and one cardiac surgeon, or by two experienced interventional cardiologists, based on local expertise, resources, and outcomes, would streamline care delivery while maintaining accountability through outcomes-based monitoring rather than prescriptive staffing requirements.

3. Programmatic Volume Thresholds and Surgeon Evaluation
Current facility, volume, and evaluation requirements should remain in place. CMS should maintain evidence-based volume thresholds for TAVR facilities to ensure that enough procedures are performed to maintain excellent clinical outcomes. Surgeon evaluation, which could be in-person or via telehealth, provides the opportunity for patients to be assessed for surgical intervention, if appropriate, which might be missed otherwise. This could inadvertently result in some patients receiving the treatment of the specialty they are referred to, rather than the treatment most clinically appropriate for their condition.

4. TVT Registry and Coverage With Evidence Development
CMS should continue mandatory TVT Registry participation. Only by continuing to require participation in the TVT Registry can CMS ensure that real-world outcomes match clinical trial results. The Section B requirement allowing coverage when performed within a CMS-approved clinical study with clinical and scientific integrity requirements should remain in place as a framework for evidence generation.

This NCD decision carries significant implications for Medicare beneficiaries who could benefit from TAVR. A policy that expands access to appropriate patients, maintains high standards through outcomes-driven oversight, preserves the multidisciplinary heart team model, and supports continued evidence development, will best serve patients and the healthcare system as transcatheter therapies continue to advance.

Thank you for your continued commitment to evidence-based, patient-centric care.
Sincerely,

Tina Ivovic
President, Healthcare Reimbursement Consulting LLC

Less

Dear Dr. Oz and CMS Leadership:

TAVR is an established and very safe procedure when performed in appropriate patients by experienced teams. Precisely because outcomes are excellent overall, even a small number of dismal outcomes—often related to patient selection, anatomy, or operator experience—can significantly harm patient trust and program integrity.

CMS’ and our goals are aligned: To provide the safest care to all populations possible.

Strong adherence to a multidisciplinary heart-team model remains the most effective mechanism to provide optimal cardiovascular care. Meaningful involvement of both interventional cardiologists and cardiac surgeons, ensures appropriate patient selection, careful anatomical assessment, and balanced consideration of long-term treatment strategies. We strongly believe sustained adherence to the heart-team model represents the most reliable mechanism to further improve upon already excellent outcomes and provide the safest care to patients. Deviating from this will potentially lead to divisive relationships, inappropriate treatment, and poor patient outcomes.

Ongoing participation in a national registry such as the STS/ACC TVT Registry remains essential. Registry-based reporting has been critical for transparency, benchmarking, quality improvement, and early identification of outcome variability related to operator experience, institutional volume, and patient selection. In the absence of mandatory reporting, poorer outcomes may go unrecognized, undermining patient safety and public trust.

Reduced transparency also risks weakening enforcement of key program requirements, including surgical backup and rigorous heart-team decision making. This may inadvertently accelerate inappropriate indication creep, such as TAVR use in younger patients with unfavorable bicuspid anatomy, marginal annular or coronary anatomy, or clinical scenarios where surgical aortic valve replacement offers superior long-term durability and lifetime management. The heart-team model also ensures that all patients are comprehensively evaluated for either surgical or catheter-based aortic valve replacement and can be informed partners in shared decision-making for lifetime management of their aortic valve disease.

Expansion of coverage to asymptomatic disease further heightens the need for oversight. Standardized reporting and audit mechanisms in this population are required to ensure appropriate indications for aortic valve replacement and to track outcomes in this population where clear mortality benefit has not yet been demonstrated.

For these reasons, while modernization of the TAVR coverage framework is warranted, we strongly urge CMS to retain requirements for national outcomes reporting, heart-team–based care, and programmatic safeguards. These measures protect patients, preserve procedural appropriateness, and enable equitable, high-quality expansion of access—particularly for underserved populations—without compromising outcomes.

Sincerely,

The University of Michigan Multidisciplinary TAVR Team
Shinichi Fukuhara, MD
Stan Chetcuti, MD
Gorav Ailawadi , MD
P Michael Grossman, MD
Bo Yang, MD
Himanshu Patel, MD
Daniel Menees, MD
G Michael Deeb, MD

Less

Comments of the National Center for Health Research
NCA CAG-00430R2: National Coverage Analysis for Transcatheter Aortic Valve Replacement (TAVR)
January 14, 2026

Thank you for the opportunity to express our views opposing a National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR) in asymptomatic severe aortic stenosis. Our recommendation is based on the scientific evidence and implications described below.

The EARLY TAVR trial does not establish a meaningful patient-centered benefit for asymptomatic Medicare beneficiaries

The EARLY TAVR trial demonstrated statistical superiority for a composite primary endpoint that combined death with disabling stroke into one variable that was part of a composite endpoint that also included stroke and unplanned cardiovascular hospitalization. This justification for coverage is flawed because using a composite measure that combines variables that vary greatly in their importance to patients resulted in a misleading conclusion.[1] This is especially true in this case because the very tiny difference in all-cause mortality and disabling stroke for the TAVR patients (11%) compared to surveillance patients (10%) was neither meaningful nor anywhere close to statistically significant, and those two outcomes are the most clinically meaningful endpoints for patients.

Composite endpoints are often used to increase event rates and statistical power, but when component outcomes differ substantially in importance to patients, as was the case here, the composite result obscures the absence of benefit for the most important outcomes. In the EARLY TAVR trial, the composite endpoint was driven largely by hospitalizations rather than survival or major disability, and undergoing TAVR within six months in the surveillance arm was prespecified to count as an “unplanned cardiovascular hospitalization.” As a result, approximately one quarter of patients in the control group who were counted as having an unplanned hospitalization had crossed over to intervention prior to a routine follow-up visit. Although this hospitalization was not planned at the start of the trial, it was not an emerging medical crisis, which is what an unplanned hospitalization suggests. It is particularly problematic because symptom self-reports often triggered crossover, and in an open-label trial of asymptomatic patients, self-reported symptoms may be influenced by patient expectations, anxiety, or dissatisfaction with assignment to surveillance.

For example, one of the interventional cardiologists involved in the study, Dr. Hemal Gada, explained that numerous patients signed up for the study because they wanted TAVR, and were disappointed when they were randomized to surveillance. He expressed his view that the substantial number of asymptomatic patients who almost immediately reported mild symptoms after being randomized to the control group reflected that disappointment, a situation that would not be expected in routine clinical care when patients are reassured that intervention is not yet medically necessary. As a co-author of the published study of EARLY TAVR, he disagreed with the way the results were presented.[2] The inclusion of early crossover hospitalizations based on self-reported mild symptoms should not have been included in the unplanned hospitalization endpoint and instead should have been studied independently.

In summary, the reported benefit of early TAVR in this trial was driven primarily by lower scores on a composite outcome that inappropriately included protocol-defined hospitalizations to convert to TAVR, not by improvements in health outcomes such as survival or prevention of a major disability.

Open-label design and adjudication awareness introduce bias in key outcome measures

The EARLY TAVR trial was open-label, and the clinical events committee adjudicating outcomes was aware of treatment assignment. This limitation is particularly relevant because the dominant contributor to the composite endpoint was “unplanned hospitalization” for cardiovascular causes, an outcome that frequently depends on clinical judgment rather than objective criteria and in this trial also was substantially influenced by surveillance arm patients’ self-reported mild symptoms leading to conversion to the treatment group. In an asymptomatic population, where symptom perception, patient anxiety, and provider thresholds for hospitalization may differ by treatment assignment, the potential for bias is substantial. As we noted above, patients in the surveillance arm were aware that they had severe aortic stenosis yet were assigned to defer intervention, and a co-author noted in a later commentary that dissatisfaction with remaining in the control group may have influenced symptom reporting, requests for intervention, and downstream hospitalization decisions.[2] These limitations, acknowledged by the study authors, should help persuade CMS that the evidence is not sufficiently robust to support national coverage.

The EARLY TAVR trial medical expertise and study participants are not representative of most Medicare patients or medical care

Participants in the EARLY TAVR trial were predominantly low surgical risk, with a mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of approximately 1.8%. That means that on average, trial participants were expected to have fewer than 2 deaths per 100 patients within 30 days of TAVR. Participants were also highly selected for anatomy suitable for transfemoral TAVR. These are ethically appropriate decisions for the research study, but it means that the study participants are not representative of the general Medicare population.

In addition, the study results are not generalizable to the Medicare population because all procedures were performed in experienced centers with intensive surveillance, rapid access to intervention, and pre-procedural planning established prior to enrollment. We agree with the study authors that this level of expertise and monitoring cannot be assumed to be replicated in routine clinical practice. In addition, the trial population was overwhelmingly White, and possible racial differences further limit the generalizability of the study results to the Medicare population.

CMS coverage decisions must be based on probable benefits to the heterogeneous Medicare population, including older and frailer patients, those with multiple comorbidities, and care settings without trial-level monitoring or rapid access to intervention. Evidence generated under the exceptional conditions of this study are not generalizable to most Medicare beneficiaries and therefore does not justify broad national coverage. Moreover, Medicare coverage of TAVR for asymptomatic patients is especially questionable given that even under these ideal circumstances there was no benefit in terms of survival or debilitating stroke.

Early crossover and other limitations weaken the case for early intervention

In the clinical surveillance arm of the EARLY TAVR trial, patients did not undergo TAVR solely after spontaneous clinical deterioration. Rather, crossover to intervention occurred based on protocol-defined triggers, including development of self-reported symptoms, changes in left ventricular function, abnormal exercise testing, biomarker thresholds, or investigator judgment under intensive monitoring. This resulted in 26.2% of patients randomized to clinical surveillance undergoing TAVR within 6 months, 47.2% by 1 year, and 71.4% by 2 years. As noted above, hospitalization for TAVR during crossover from the clinical surveillance group to intervention, was classified as an unplanned cardiovascular hospitalization.[3]

During closely monitored surveillance, concerns and the possible need for intervention generally cause anxiety and lower quality of life, whereas prompt intervention results in lower anxiety and higher quality of life scores. These differences are inevitable and are not an indication that the surveillance itself causes harm. Quality-of-life findings in the trial must therefore be interpreted with caution. Temporary declines in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores observed among some surveillance patients occurred in the period immediately preceding crossover and were followed by rapid improvement after TAVR.[3] Moreover, as previously noted, patients who joined the trial hoping for access to TAVR and who were disappointed to be randomly assigned to the surveillance group would likely report the types of changes noted in quality of life during surveillance and after treatment, independent of any true clinical benefit or harm.[3] Dr. Hemal Gada pointed out that patients randomized to surveillance were aware that they had severe aortic stenosis yet were assigned to defer intervention, and that situation may have generated dissatisfaction, anxiety, or heightened symptom reporting that would not be expected in routine clinical care when patients are reassured that intervention is not yet medically necessary.[2] This trial-specific dynamic limits the implications of the quality-of-life data, weakening their relevance to a decision about broad Medicare coverage of an early, irreversible intervention in asymptomatic patients.

Given the problems with the study design, CMS should be reluctant to make a coverage decision that would encourage Medicare asymptomatic beneficiaries to earlier lifelong device implantation, potential re-interventions, and downstream complications without clear evidence of survival or disability benefit. Earlier implantation of a bioprosthetic valve also raises concerns about valve durability and the cumulative risks and costs of repeat interventions over a beneficiary’s lifetime, outcomes not addressed by the EARLY TAVR trial.

Limited long-term durability data support delaying irreversible valve implantation in asymptomatic patients

All implanted bioprosthetic valves deteriorate over time and may eventually require repeat intervention. Contemporary TAVR devices have thus far been studied for up to 5 years, with limited evidence beyond that timeframe.[4,5,6] Clear evidence regarding how long TAVR valves last is especially needed to determine if patients who are asymptomatic should undergo TAVR surgery a year or more before it is necessary.

In EARLY TAVR and similar low-risk trials, patients had a mean age in the mid-70s and relatively low surgical risk, suggesting an expected survival of roughly 8-10 years or longer. In this context, performing TAVR earlier in the disease course increases the likelihood that asymptomatic patients may outlive their first transcatheter valve, raising the risk of structural valve deterioration and the need for repeat valve procedures.

At our request, an analysis was conducted by the nationally respected company DeviceEvents which extracts, consolidates, and provides clear metrics on complex medical device adverse events (MDRs) that have been filed with the FDA. Their analysis identified more than 14,000 adverse event reports of perivalvular or paravalvular leakage for TAVR devices. The reports often do not provide data on when the TAVR procedure took place, but these reports, which increase every year, reinforce our concerns that long-term durability of TAVR valves needs to be carefully studied prior to considering Medicare TAVR coverage for asymptomatic patients.

Delaying TAVR until patients become symptomatic preserves the option of valve replacement when clinical benefit is clear, while reducing cumulative lifetime exposure to device failure, repeat intervention, and associated procedural risks. This consideration is particularly relevant for coverage policy decisions involving irreversible device implantation in asymptomatic patients with substantial remaining life expectancy.

Standards for FDA approval differ from standards for Medicare coverage

FDA approval of medical devices is based on a “reasonable assurance” of safety and effectiveness for patients of unspecified age and health status, whereas CMS is statutorily required to determine whether an intervention is “reasonable and necessary” for the Medicare population. The average Medicare patient is approximately 75 years old, 40% are 75 years and older, and 10% are 85 years and older.[7] Older Medicare patients are more vulnerable to poor surgical outcomes than the patients in the EARLY TAVR trial, who were a similar average age but were predominantly low surgical risk, with careful selection and intensive monitoring. This is another reason why the results do not provide evidence that coverage is reasonable and necessary for a Medicare population, since the outcomes that matter most to Medicare beneficiaries are survival, independence, quality of life, and avoidance of major disability. Coverage policy should not move ahead of the evidence, particularly for an irreversible intervention that may expose asymptomatic beneficiaries to substantial out-of-pocket costs and downstream financial burden. In the absence of demonstrated patient-centered benefit, expanding coverage also raises concerns about opportunity costs and the efficient use of limited Medicare resources.

Recommendations

Given the current evidence, CMS should:

• Decline to issue or expand a National Coverage Determination for TAVR in asymptomatic severe aortic stenosis. CMS should consider Coverage with Evidence Development only if future data demonstrate a clear benefit in terms of survival and disability, with useful evidence indicating the devices are safe and effective for more years than patients are likely to need them.
• To meet criteria for an NCD, CMS should require additional trials and longer-term follow-up focused on individual variables that include all-cause mortality, disabling stroke, valve durability, and real-world patient-centered outcomes. Until such evidence is available, expanding national coverage would expose Medicare beneficiaries to substantial risk and cost without proven improvement in outcomes that matter most to them.

References

1. Freemantle, N., Calvert, M., Wood, J., Eastaugh, J., & Griffin, C. (2003). Composite outcomes in randomized trials: greater precision but with greater uncertainty?. Jama, 289(19), 2554-2559.
2. https://cardiovascularbusiness.com/topics/clinical/structural-heart-disease/tavr/cardiologist-early-tavr-asymptomatic-fda-approval
3. Généreux, P., Schwartz, A., Oldemeyer, J. B., Pibarot, P., Cohen, D. J., Blanke, P., ... & Leon, M. B. (2025). Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. New England Journal of Medicine, 392(3), 217-227.
4. FDA CoreValve™ Evolut™ R Transcatheter Aortic Valve Delivery Catheter System: https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130021S058d.pdf
5. FDA Edwards SAPIEN 3Transcatheter Heart Valve with the Edwards Commander Delivery
6. System: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031c.pdf
6. Mack, M. J., Leon, M. B., Thourani, V. H., Makkar, R., Kodali, S. K., Russo, M., ... & Smith, C. R. (2019). Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. New England Journal of Medicine, 380(18), 1695-1705.
7. KFF Medicare Beneficiaries by Age, 2024, https://www.kff.org/medicare/state-indicator/medicare-beneficiaries-by-age/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D

Less

January 14, 2026

Sarah Fulton, MHS
Lead Analyst, NCA for TAVR (CAG-00430R2)
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments on National Coverage Determination (NCD) Reconsideration Request for Transcatheter Aortic Valve Replacement (TAVR) 20.32: Strategic Amendment to Section B to Enable Seamless Coverage Transition for FDA Approved Indications

Dear Ms. Fulton,

JenaValve Technology, Inc. respectfully submits these comments in response to the National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) initiated on December 15, 2025, in response to a formal reconsideration request submitted by Edwards Lifesciences on July 28, 2025. As the developer and manufacturer of the Trilogy™ Heart Valve System, an FDA designated Breakthrough Device and the only TAVR system specifically designed to treat aortic regurgitation (AR, a condition affecting 2.0% of patients aged 75 and older [1]), JenaValve has a unique perspective on the evolving landscape of transcatheter aortic valve therapies and the infrastructure necessary to ensure patient access to innovative, lifesaving treatments. JenaValve has three active studies that are covered under Section B of the NCD; the ALIGN-AR Trial, which is currently in a Continued Access Protocol (CAP), the ARTIST Study, and the JENA-VAD Registry.

The Edwards request contains three primary elements: 1) expanding coverage to asymptomatic patients, 2) Coverage with Evidence Development (CED) requirements, and 3) eliminating facility/evaluation requirements. While we support efforts to expand patient access to life saving TAVR therapy, we believe that modification without appropriate safeguards, would compromise patient safety, dismantle critical quality infrastructure, and eliminate essential oversight. In particular, a critical modification that should be made to the NCD is to revise it so that a use that has been covered via an approved study or registry does not lose coverage solely because that use is approved by the FDA, as the current language of Nationally Covered Indication "B" dictates.

A critical historical precedent underscores these concerns: when CMS ended mandatory registry participation for implantable cardioverter defibrillators (ICDs) in February 2018, hospital participation dropped approximately 55%, from over 1,800 hospitals to approximately 800 hospitals in 3 years [2]. This fundamental loss of surveillance infrastructure cannot be replaced by manufacturer conducted FDA post approval studies that focus on limited patients and hospitals and are not representative of underserved, covered beneficiaries [3, 4].

Evidence from Aortic Regurgitation: Clinical evidence demonstrates the critical importance of maintaining CED requirements for emerging indications. The ALIGN-AR pivotal trial (700 patients) of the Trilogy™ Heart Valve System achieved 95% technical success and 7.7% 1-year mortality versus a 25% performance goal (p<0.0001) [8]. In contrast, the PANTHEON registry documented the limitations of off label TAVR for AR: only 83.6% technical success, 12.4% device embolization/migration, and 9.2% residual moderate/severe AR [9]. A meta-analysis of 2,162 patients confirmed dedicated devices achieve superior outcomes: 30-day mortality 3% vs. 9%, device success 93% vs. 82%, and 1-year mortality 6% vs. 24% compared to off label devices [10]. Without CED requirements, Medicare would reimburse off label devices despite inferior outcomes, while manufacturers who invested in indication specific trials would face unfair competition.

JenaValve proposes modification of Section B of the TAVR NCD to enable the coverage with evidence development of uses regardless of an FDA approved indication for the use. That revision will end the perverse result of Medicare having to discontinue coverage under a CMS approved study or registry solely due to the FDA approval of an indication for use.

I. PROPOSED AMENDMENT TO SECTION B: SEAMLESS COVERAGE TRANSITION PATHWAY

JenaValve proposes a strategic amendment to Section B of the TAVR NCD that would establish a clear, predictable pathway for devices that have successfully completed CMS approved clinical studies to transition from Section B coverage to full Section A coverage upon FDA approval. This proposal addresses a specific gap in the current NCD framework that requires repeatedly opening the TAVR NCD when new indications are approved, while preserving quality safeguards.

A. Current Challenge

Under the current NCD structure:

The current Section B language creates a problematic cliff: when a device successfully completes Section B clinical studies and subsequently receives FDA approval for a new indication (such as aortic regurgitation), coverage under Section B would terminate because the use is no longer "not expressly listed as an FDA approved indication." However, if Section A does not encompass the newly approved indication, a coverage gap results. While CMS has an established mechanism for expanding coverage following successful CED, namely reconsideration of the NCD, the timing of FDA approval and NCD reconsideration may not align, leaving Medicare beneficiaries without coverage for the FDA approved, purpose built device.

B. Proposed Solution: Automatic Transition Pathway

We propose adding the following language to Section B of the NCD:

———————————————————————————————————————— PROPOSED LANGUAGE: Section B Amendment

"C. Transition to Section A Coverage for FDA Approved TAVR Devices

When a TAVR device and implantation system that has been covered under Section B of this NCD subsequently receives FDA premarket approval (PMA) for an indication addressed in the CMS approved clinical study:

(1) Coverage shall automatically transition to Section A of this NCD, effective on the date of FDA approval, provided that:

(2) The transitioning device shall participate in the national audited registry specified in Section A, beginning on the date of FDA approval.

(3) CMS will provide written confirmation of transition to Section A coverage within 60 days of receiving complete documentation. During this confirmation period, coverage under Section A shall continue without interruption.

(4) For devices treating indications not currently specified in Section A, Section A coverage criteria shall apply, with the new indication automatically incorporated into Section A upon FDA approval." ————————————————————————————————————————

II. RATIONALE AND BENEFITS OF THE PROPOSED AMENDMENT

A. Benefits for CMS and the Medicare Program

B. Benefits for Patients

C. Benefits for Industry and Innovation

D. Benefits for the Healthcare System

III. POSITION ON RECONSIDERATION REQUESTS

JenaValve provides the following assessment of the three primary elements of the Edwards reconsideration request:

A. Expansion to Asymptomatic Patients: Conditional Support

We acknowledge that the FDA approved the SAPIEN 3 platform for asymptomatic severe aortic stenosis in May 2025, based on the EARLY TAVR trial [7].

We respectfully note critical considerations:

Recommendation: If CMS determines that coverage expansion to asymptomatic patients is appropriate, we strongly urge that registry requirements are maintained.

B. Removal of CED Requirements: Oppose Complete Elimination

We have concern that the complete removal of CED requirements would diminish TVT Registry participation and data quality and would remove the CMS study requirement for off label TAVR.

The ICD Registry Precedent: Historical evidence demonstrates the consequences of removing mandatory registry participation. When CMS ended mandatory participation for ICDs in February 2018, hospital participation decreased by 55% by 2021 [2]. This represents a fundamental loss of valuable surveillance infrastructure.

Why FDA Post-Approval Studies Cannot Replace Mandatory Registries: FDA post-approval studies and CMS mandated registries serve fundamentally different purposes and cannot be treated as interchangeable surveillance mechanisms [3, 4]:

Impact on Emerging Indications: Removing the CMS study requirement for off label uses would:

Recommendation: CMS should continue mandatory TVT Registry participation regardless of CED status and maintain the CMS study requirement for uses beyond FDA approved indications to preserve quality and the evidence generation framework.

C. Facility and Evaluation Requirements: Maintain with Flexibility

We have concerns about eliminating facility, volume, and evaluation requirements without appropriate safeguards.

Mandatory Surgeon Evaluation: The current NCD requirement for evaluation by a cardiac surgeon ensures that patients receive appropriate assessment of whether TAVR, surgical aortic valve replacement (SAVR), or medical management is the optimal treatment pathway. This multidisciplinary Heart Team approach reflects ACC/AHA Class I recommendations. Removing mandatory surgeon evaluation would:

Heart Team Evaluation: The 2021 ESC/EACTS Guidelines explicitly warn that "it is no longer appropriate for referring physicians to send patients directly to their preferred surgeon or cardiologist" given the complexity of treatment decisions and the need for multidisciplinary evaluation [13]. The Heart Team requirement exists precisely to ensure that clinical appropriateness, rather than referral patterns, determines patient care.

Volume Thresholds: Substantial evidence demonstrates a volume outcome relationship in structural heart procedures. Vemulapalli et al. (NEJM 2019) found low volume centers had 3.19% vs. 2.66% 30-day mortality, a 20% relative increase in risk [14]. Current geographic access data do not support claims of inadequate availability: Marquis-Gravel et al. (JAMA Cardiology 2020) found median driving time was 35 minutes (IQR: 20 to 70 minutes), and 92.1% of the U.S. population aged 65+ lived in a hospital referral region with a TAVR center [6].

Surgical Backup: The requirement for cardiac surgery capability on site exists because TAVR complications, including annular rupture, coronary obstruction, and severe paravalvular leak, may require emergent surgical intervention. While such complications are infrequent, they can be fatal without immediate surgical capability.

Recommendation: Maintain surgical evaluation with Heart Team flexibility, supporting telehealth options for surgeon evaluation when in person assessment is not feasible. Maintain evidence based volume thresholds for TAVR sites with periodic review as technology and evidence evolve. We recommend STS, ACC, SCAI, and ASE collaborate with CMS to establish appropriate thresholds based on current evidence.

IV. ADDITIONAL CONSIDERATIONS FOR NCD RECONSIDERATION

History demonstrates the critical importance of robust post-market surveillance:

These precedents—-both domestic and international—-underscore why mandatory registry participation must be preserved as TAVR expands to new indications and patient populations.

V. SUMMARY OF RECOMMENDATIONS

JenaValve respectfully urges CMS to:

1. Adopt the proposed Section B amendment: Establish an automatic transition pathway from Section B to Section A coverage upon FDA approval for devices that have successfully completed CMS approved clinical studies, maintaining registry participation and all quality safeguards.
2. Expand the NCD scope: Encompass all TAVR indications, including aortic regurgitation, under a unified coverage framework that maintains quality requirements.
3. Support expansion to asymptomatic AS patients with maintained oversight: If CMS determines that coverage expansion to asymptomatic patients is appropriate based on the EARLY TAVR evidence, such expansion should be accompanied by maintained, not eliminated, registry requirements and quality oversight.
4. Continue mandatory TVT Registry participation regardless of CED status: The ICD Registry precedent demonstrates the consequences of removing mandatory participation, a 55% collapse in hospital participation. Registry infrastructure must be preserved to maintain national outcomes tracking and quality improvement.
5. Maintain the CMS study requirement for off label uses: Continue requiring that TAVR procedures for uses not expressly listed as FDA approved indications be performed in CMS approved clinical studies to preserve evidence generation and prevent unfair competition between indication specific approved devices and off label use.
6. Maintain mandatory surgeon evaluation requirements: Preserve the multidisciplinary Heart Team approach that ensures patients receive appropriate treatment pathway assessment, consistent with ACC/AHA Class I recommendations.
7. Maintain evidence based volume thresholds with periodic review: Ensure procedural competency and optimal patient outcomes. We recommend STS, ACC, SCAI, and ASE collaborate with CMS to establish appropriate thresholds based on current evidence, including the Vemulapalli et al. (2019) NEJM volume outcome study.
8. Maintain surgical backup with Heart Team flexibility: Preserve the safety net for life threatening complications, while supporting telehealth options for surgeon evaluation when in person assessment is not feasible.

VI. CONCLUSION

The TAVR NCD has successfully balanced patient access with quality and safety through thoughtful requirements for facility capabilities, operator experience, multidisciplinary evaluation, and outcomes tracking. The TVT Registry has documented remarkable improvements in TAVR outcomes, with 30-day mortality declining from 7.6% (2011-2013) to 2.3% (2019) [5, 6]. This infrastructure must be preserved as TAVR expands to new indications and patient populations.

JenaValve's proposed Section B amendment offers a balanced path forward that addresses the legitimate need for streamlined coverage pathways while preserving essential quality safeguards. The clinical evidence from aortic regurgitation demonstrates why this approach matters: the ALIGN-AR trial achieved 95% technical success with purpose-built devices [8], while off label use of AS designed devices yields markedly inferior outcomes [9, 10]. Maintaining CED requirements for off label uses ensures that patients receive devices specifically designed, tested, and approved for their condition.

The ICD Registry precedent, with its 55% collapse in hospital participation after CMS ended mandatory requirements [2], demonstrates that these concerns are not theoretical. The proposed Section B amendment would:

JenaValve urges CMS to adopt the proposed Section B amendment and to preserve the quality infrastructure that has made TAVR one of the most successful medical technology introductions in cardiovascular medicine. We remain committed to working with CMS to ensure that Medicare beneficiaries have access to safe, effective, and innovative TAVR therapies.

Thank you for the opportunity to provide these comments.

Respectfully submitted,

Courtney Darby
Head of Health Economics, Market Access and Reimbursement
JenaValve Technology, Inc.

REFERENCES

[1] Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-1011.

[2] Masoudi FA, Oetgen WJ. The NCDR ICD Registry: A Foundation for Quality Improvement. J Am Coll Cardiol. 2017;70(14):1792-1794. (Documents >1,800 hospitals participating before CMS mandate ended); American College of Cardiology. "ACC Launches NCDR EP Device Implant Registry." Press Release, April 2, 2021. Available at: https://www.acc.org/about-acc/press-releases/2021/04/02/13/24/acc-launches-ncdr-ep-device-implant-registry. (Documents ~800 hospitals participating after mandate ended.)

[3] Rajan PV, Kramer DB, Kesselheim AS. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies. JAMA Intern Med. 2015;175(11):1773-1779.

[4] Resnic FS, Normand SL. Drugs, devices, and the FDA: Part 2: An overview of approval processes. Circulation. 2018;138(12):e218-e229.

[5] Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020;76(21):2492-2516.

[6] Marquis-Gravel G, Stebbins A, Kosinski AS, et al. Geographic Access to Transcatheter Aortic Valve Replacement Centers in the United States. JAMA Cardiol. 2020;5(9):1006-1010.

[7] Généreux P, Schwartz A, Oldemeyer JB, et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2024;392:217-227. (EARLY TAVR Trial)

[8] Makkar RR, et al. TAVR With JenaValve for Symptomatic Aortic Regurgitation in High Surgical Risk Patients: ALIGN-AR Trial Results. Presented at ACC.25, Chicago, March 30, 2025. [Lancet publication anticipated]

[9] Poletti E, De Backer O, Scotti A, et al. Transcatheter aortic valve replacement for pure native aortic valve regurgitation: The PANTHEON International Project. JACC Cardiovasc Interv. 2023;16(16):1974-1985.

[10] Samimi S, Hatab T, Kharsa C, et al. Meta-Analysis of Dedicated vs Off-Label Transcatheter Devices for Native Aortic Regurgitation. JACC Cardiovasc Interv. 2024 (published online November 20, 2024).

[11] O'Brien SM, Shahian DM, Filardo G, et al. The Society of Thoracic Surgeons 2008 Cardiac Surgery Risk Models: Part 2, Isolated Valve Surgery. Ann Thorac Surg. 2009;88(1 Suppl):S23-42. (STS database analysis showing 79.9% of SAVR patients were low risk [STS-PROM <4%] and 13.9% were intermediate risk [STS-PROM 4-8%], with only 6.2% at high risk.)

[12] Thourani VH, Suri RM, Gunter RL, et al. Survival After Surgical Aortic Valve Replacement in Low-Risk Patients: A Contemporary Trial Benchmark. Ann Thorac Surg. 2023;117(1):93-102.

[13] Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022;43(7):561-632.

[14] Vemulapalli S, Carroll JD, Mack MJ, et al. Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. N Engl J Med. 2019;380(26):2541-2550.

[15] Hauser RG, Hayes DL. Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure. Heart Rhythm. 2009;6(5):605-610.

[16] FDA Class I Device Recall: Medtronic Sprint Fidelis Lead. October 2007.

[17] 2010 DePuy Hip Replacement Recall. Data from UK National Joint Registry showed 13% failure rate at 5 years for ASR XL Acetabular system.

[18] FDA. Concerns about Metal-on-Metal Hip Implants. Updated 2024. Australian Orthopaedic Association Registry identified problems before U.S. detection.

[19] National Institute for Health and Care Excellence (NICE). Transcatheter heart valves for transcatheter aortic valve implantation to treat aortic stenosis: late-stage assessment (HTG757). Published August 21, 2025. Available at: https://www.nice.org.uk/guidance/htg757. Heart Valve Voice. Statement on NICE Late-Stage Assessment Guidance for Transcatheter Aortic Valves. August 22, 2025 (noting that "Strengthening real-world evidence, particularly through the UK TAVI Registry, will be critical to future evaluations").

Less

Dear CMS officials,

I am an interventional cardiologist practicing in Boise, Idaho, for the past 7 years. I have been privileged to be a part of a successful team with excellent transcatheter aortic valve replacement (TAVR) outcomes despite facing our challenges, including limited physician resources. Part of my commentary will highlight a few considerations unique to my practice. As of 2026, TAVR is a well-established therapy that has demonstrated effectiveness in treating severe aortic stenosis with low rates of major complications.

In summary, I write to address my perspective on the following points:

1. Evaluation for aortic valve replacement should be done by a heart team involving implanters of transcatheter and surgical valves.
2. Performing the TAVR procedure has become safer over time, reducing the incidence of conversion to bailout emergency open cardiac surgery.
3. TAVR is best performed by two experienced operators. A single operator performing TAVR has not been evaluated by studies using the current valve implant systems.
4. There should be flexibility for heart teams to perform TAVR according to local expertise. This would allow an interventional cardiologist and cardiac surgeon to continue to operate together, or two experienced cardiac surgeons as co-operators, or two experienced interventional cardiologists as co-operators depending on local availability, skill, and experience of operators.
5. Patients with classic severe aortic stenosis should be eligible for TAVR, including those patients reporting no symptoms.

In my view, one of the greatest byproducts that came from the emergence of TAVR was the establishment of heart teams all across the United States. This has increased collaboration of specialists addressing aortic stenosis and other complex cardiac issues, including other valvular heart disease and coronary artery disease. TAVR is suitable in most patient anatomies. But, there are nuances in which patients who are low or moderate risk may benefit more from a surgical aortic valve replacement. Some of these considerations include the need for coronary revascularization, hostile valve anatomy for TAVR, presence and morphology of a bicuspid aortic valve, ascending aortopathy, concomitant valvular heart disease, and planning for lifetime management of patients. Risks of either modality will continue to be best evaluated from a multi-specialty approach.

Idaho has the lowest physician-to-population ratio in the United States. Our team takes care of a population in a large geographic area that is generally underserved. Our heart team previously had three cardiac surgeons. However, over the past four to five years, we have only had two cardiac surgeons to support our ever-growing patient population in this area. This has necessitated the use of some Locum Tenens surgeons to fill in coverage gaps, with various experience with TAVR. This has been disruptive to patient care, as the procedure is best performed with two operators who are familiar with each other and have established a regular workflow and cadence. In my experience, successful TAVR procedures require a consistent team with strong working relationships. In our particular situation, this has occasionally affected the timeliness of care.

At one point during the COVID-19 pandemic, we were reduced to one cardiac surgeon and two interventional cardiologists at our hospital. This severely strained our ability to provide care to the people of this region who urgently needed this life-saving procedure. Fortunately, as part of increased flexibility during this public health emergency (PHE), there was temporary permission given by CMS to perform the procedure without the traditional one cardiac surgeon, one interventional cardiologist requirement. This gave my particular program more flexibility to continue to treat the patients who were suffering due to the effects of severe aortic stenosis. For the two years this was in place, our outcomes remained good, and better than the national average. Throughout this time, we continued to improve with two interventional cardiologists performing the procedure. We also participated in a publication which suggests there were no differences in outcomes during the PHE time period.

In various practices, surgeons have differing degrees of interest and involvement in the procedure. I recognize that in some programs, surgeons perform the majority of the procedure with the interventional cardiologist playing a more minor role. In our particular practice, our surgeons are very supportive and participate in each procedure, but play a relatively minor role in completing the full job. This is in part due to their need for other clinical care and procedures that only they can do. Local heart teams need the flexibility to direct the best way to take care of their patients. While the need for bailout emergency cardiac surgery during TAVR is possible, this is also true for coronary angiography and PCI. The CENTER2 data reported the need for surgical bailout at 0.52%, with this number decreasing over time.

There may be cases in which surgery is more involved, such as cut downs for alternative access. There are also cases where coronary obstruction is a potential concern with coronary protection, and interventional cardiologists can be involved in those cases. These considerations should be left to individual heart teams based on their strengths and limitations.

As you know, there is evidence for the treatment of severe asymptomatic aortic stenosis in patients with high gradient aortic stenosis. There is a larger risk in waiting to treat patients who are otherwise good candidates. We do see patients wait too long for treatment, and the consequences have been devastating. Given the outcomes of the EARLY TAVR trial data, asymptomatic severe aortic stenosis should be eligible for treatment.

Less

Aortic regurgitation is a serious and life threatening condition who's treatment options have lacked commercially-available, minimally invasive treatment options despite 20 years of advancements in transcatheter treatment of aortic stenosis. In the current era, without TAVR for aortic regurgitation, only roughly half of patients with severe or moderate-severe aortic regurgitation undergo Heart Team evaluation for aortic valve replacement within 2-years of diagnosis despite guideline recommendations.[1] Clearly, there is an unmet need for treatment options (such as TAVR) beyond surgery. Much like TAVR for aortic stenosis increased overall patient care without decreasing surgery for appropriate candidates, we expect TAVR for aortic regurgitation would improve patient treatment rates and population prognosis.

. The ALIGN-AR pivotal trial (700 patients) of the Trilogy™ Heart Valve System achieved 95% technical success and 7.7% 1-year mortality versus a 25% performance goal (p<0.0001).[2] In contrast, the PANTHEON registry documented the limitations of off label TAVR for AR: only 83.6% technical success, 12.4% device embolization/migration, and 9.2% residual moderate/severe AR [3]. A meta-analysis of 2,162 patients confirmed dedicated devices achieve superior outcomes: 30-day mortality 3% vs. 9%, device success 93% vs. 82%, and 1-year mortality 6% vs. 24% compared to off label devices [4].

My experience with treating aortic regurgitation patients in the ALIGN-AR trial, as well as off-label, the past 7 years yields clinical observation commiserate with the above literature. As an interventional cardiologist whose primary clinical practice focuses on treating structural heart disease as well as investigational medical device use, I see the benefits of transcatheter therapies, the interdisciplinary approach with cardiology and cardiac surgery, and current TAVR-for-aortic stenosis paradigm on a daily basis. Accordingly, I'd make the below recommendations:

1. Adopt the proposed Section B amendment: Establish an automatic transition pathway from Section B to Section A coverage upon FDA approval for devices that have successfully completed CMS approved clinical studies, maintaining registry participation and all quality safeguards.
2. Expand the NCD scope: Encompass all TAVR indications, including aortic regurgitation, under a unified coverage framework that maintains quality requirements.
3. Support expansion to asymptomatic AS patients with maintained oversight: If CMS determines that coverage expansion to asymptomatic patients is appropriate based on the EARLY TAVR evidence, such expansion should be accompanied by maintained, not eliminated, registry requirements and quality oversight.
4. Continue mandatory TVT Registry participation regardless of CED status: The ICD Registry precedent demonstrates the consequences of removing mandatory participation, a 55% collapse in hospital participation. Registry infrastructure must be preserved to maintain national outcomes tracking and quality improvement.
5. Maintain the CMS study requirement for off label uses: Continue requiring that TAVR procedures for uses not expressly listed as FDA approved indications be performed in CMS approved clinical studies to preserve evidence generation and prevent unfair competition between indication specific approved devices and off label use.
6. Maintain mandatory surgeon evaluation requirements: Preserve the multidisciplinary Heart Team approach that ensures patients receive appropriate treatment pathway assessment, consistent with ACC/AHA Class I recommendations.
7. Maintain evidence based volume thresholds with periodic review: Ensure procedural competency and optimal patient outcomes. We recommend STS, ACC, SCAI, and ASE collaborate with CMS to establish appropriate thresholds based on current evidence, including the Vemulapalli et al. (2019) NEJM volume outcome study.

Thank you for your continued work to enable safe care for the American public.

References

1. Amoroso NS, Sharma RP, Généreux P, et al. Clinical journey for patients with aortic regurgitation: A retrospective observational study from a multicenter database. Catheter Cardiovasc Interv. 2024 Jul;104(1):145-154. doi: 10.1002/ccd.31085. Epub 2024 May 19.

2. Makkar RR, et al. TAVR With JenaValve for Symptomatic Aortic Regurgitation in High Surgical Risk Patients: ALIGN-AR Trial Results. Presented at ACC.25, Chicago, March 30, 2025.

3. Poletti E, De Backer O, Scotti A, et al. Transcatheter aortic valve replacement for pure native aortic valve regurgitation: The PANTHEON International Project. JACC Cardiovasc Interv. 2023;16(16):1974-1985.

4. Samimi S, Hatab T, Kharsa C, et al. Meta-Analysis of Dedicated vs Off-Label Transcatheter Devices for Native Aortic Regurgitation. JACC Cardiovasc Interv. 2024 (published online November 20, 2024).

Less

Dear CMS Leadership,

On behalf of the Corewell Health West Transcatheter Aortic Valve Replacement (TAVR) Program and the cardiac surgeons, we write to express our strong concerns regarding CMS’s consideration of removing the requirement that TAVR procedures be performed by a cardiac surgeon and interventional cardiologist.

Over the past 15 years we have performed over 4000 TAVRs at our institution and have played a pivotal role in the randomized trials that have brought TAVR to the forefront for the treatment of aortic stenosis. In every one of these trials, the outstanding outcomes have been the result of the collaboration of the Heart Team, comprising of a structural cardiac surgeon and cardiologist. The cardiac surgeon is key not only in the pre-procedural stages with regards to access and potential surgical bailout options, but also with regards to managing intraoperative catastrophes that may require cardiopulmonary bypass and ultimately, surgery.

We are now entering an era where TAVR may be the primary treatment option for all patients with aortic stenosis. Since the approval of low -risk TAVR in 2019 we are only now beginning to see the 5-10 year outcomes of TAVR in the younger population. Consequently, the number of TAVR explantations is rising exponentially in the US and the surgical outcomes portend significant mortality and morbidity. For many patients, lifetime management of aortic valve disease will require critical decision making by the Heart Team. This discussion may involve the Ross procedure, potential TAV-in-SAVR, TAV-in-TAV and redo SAVR in order best serve our patients. Each of these scenarios can only be considered by an experienced cardiac surgeon.

Removing the Heart Team Model from TAVR risks inappropriate use of transcatheter valve technologies, but more importantly, may jeopardize the safety and quality standards of these procedures.

We strongly advocate that CMS maintains the requirement of the Heart Team model, comprising of a cardiac surgeon and interventional cardiologist for all TAVR procedures.

Sincerely

Stephane Leung, MD
Surgical Director, Structural Heart and Valve Center

William Merhi, MD
Medical Director, Structural Heart and Valve Center

Corwell Health West
Grand Rapids, Michigan

Less

Public Comment of Members of the Patient, Consumer, and Public Health Coalition
NCA CAG-00430R2: National Coverage Analysis for Transcatheter Aortic Valve Replacement (TAVR)

We appreciate the opportunity to express our views as members of the Patient, Consumer, and Public Health Coalition. Our Coalition of nonprofit organizations represents millions of patients and consumers who are concerned about the safety, effectiveness, and affordability of medical and consumer products that have the potential to benefit the health and well-being of adults and children.

We believe that a National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR) in asymptomatic severe aortic stenosis is dangerously premature because of the lack of meaningful data supporting this indication as reasonable and necessary for Medicare patients.

We disagree with those who cite the EARLY TAVR trial as sufficient evidence that the benefits outweigh the risks for Medicare patients. The trial’s finding of a benefit for asymptomatic patients was based on a composite score that combined 3 variables: death or disabling stroke as one variable, stroke, and unplanned cardiovascular hospitalization. There was no statistically significant benefit for all-cause mortality or disabling stroke (those combined were 10% and11% of the patients in the TAVR or control group, respectively) and those are the results most meaningful to patients. Stroke also did not significantly differ.

The difference that contributed to the apparent benefit based on the composite measure was unplanned cardiovascular hospitalization, but that variable was terribly flawed. As the study authors explained, one in four patients in the non-treatment control group switched to the TAVR treatment within the first 6 months of the study, and these were counted by the study authors as “unplanned cardiovascular hospitalization.” While an unplanned hospitalization would usually be considered an important negative outcome by patients and their physicians, it would not be considered a meaningful negative outcome for asymptomatic patients who merely decided that they wanted to undergo a medical procedure that was not considered medically necessary at that time.

We are also concerned that the EARLY TAVR trial patients and medical professionals are not representative of Medicare patients in the U.S. and therefore the data do not provide evidence of benefit for Medicare patients. The patients were disproportionately White and they were also low surgical risk according to their mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score. Moreover, all procedures were performed in experienced medical centers with intensive surveillance and safeguards in place, which the study authors admitted are not typical of U.S. medical facilities.

We also want to emphasize that any implanted device tends to deteriorate over time, and many need to be replaced within 5-10 years. TAVR valves have been studied for up to approximately 5 years, and longer-term durability data are not yet available. If TAVR patients are expected to survive an average of 8-10 yrs, it makes sense to delay TAVR procedures until the patient is symptomatic, to reduce the chances that the valve will need to be replaced.

We question why Medicare would want to promote a procedure that would result in asymptomatic beneficiaries relying on an implanted device earlier than necessary — given its potential complications and need for replacement — despite the lack of evidence of survival or disability benefit.

Coverage policy should be based on clear evidence, especially for an irreversible intervention for asymptomatic patients. Surgery has risks for all patients, and especially for an aging Medicare population, 40% of whom are 75 and older and 10% who are 85 and older. We are also concerned about safeguarding Medicare resources so that they are available for treatments that are proven reasonable and necessary.

We therefore recommend CMS reject a NCD at this time, but encourage additional trials and longer-term follow-up focused on all-cause mortality, disabling stroke, valve durability, and real-world patient-centered outcomes.

Sincerely,

Cancer Prevention and Treatment Fund
Jacobs Institute of Women's Health
Medical Device Problems
Mothers Against Medical Error
National Alliance for Hispanic Health
Our Bodies Ourselves
Patient Safety Action Network
The TMJ Association
USA Patient Network
Washington Advocates for Patient Safety
Woody Matters

Less

January 14, 2026

Joanna Baldwin
Interim Director, Coverage and Analysis Group (CAG)
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

RE: Transcatheter Aortic Valve Replacement National Coverage Analysis - CAG-00430R2

Dear Ms. Baldwin,

On behalf of the Heart and Valve Collaboratory (H&VC), a 501-c-3 not for profit private public partnership, we appreciate the opportunity to provide comments on the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Analysis (NCA). The H&VC is a multistakeholder collaborative community with a mission to identify evidence gaps in the care of patients with valvular and heart disease and provide innovative solutions. The comments contained here are authored solely by the clinical and academic physicians on the H&VC, independent of and with no input from any H&VC members from governmental agencies or industry sponsors.

We request that CMS consider our comments on the following four areas:

Coverage of Treatment of Patients with Asymptomatic Aortic Stenosis

We support the request for coverage of patients with asymptomatic, severe AS. The EARLY TAVR trial showed benefits for treatment with early TAVR compared with active surveillance. Furthermore, we recommend as a condition of coverage of this indication, a provision of Coverage with Evidence Development (CED) to assure that patient care in Medicare beneficiaries with asymptomatic AS is reasonable and necessary for this indication. In addition, we recommend updating the NCD to include any new FDA-approved indications such as asymptomatic AS and future expansion of indications for conditions like aortic regurgitation, moderate AS, and bicuspid aortic valve disease. This “evergreen coverage” could be termed “any FDA approved indication of aortic valve disease”

Provisions to Maintain the Heart Team

Renewal of Coverage with Evidence Development (CED)

CMS’s decision to cover TAVR under CED with mandatory TVT Registry participation has been a highly successful model of evidence-based coverage policy. We also agree that the original questions regarding TAVR in various risk strata addressed under CED have been satisfactorily answered. However, as indication expansion continues, new questions are being raised and critical evidence gaps remain, including asymptomatic severe aortic stenosis, bicuspid aortic valve disease, younger patients under 65 years, valve-in-valve strategies (TAV in SAV, TAV in TAV), multivalvular disease, aortic regurgitation, and moderate aortic stenosis where randomized evidence is still being generated. The TVT Registry is uniquely positioned to generate the clinical evidence to demonstrate benefit in Medicare beneficiaries and inform future clinical research initiatives. While mandatory registry participation has created some burden to clinical sites, the benefits far outweigh the burden and cost. Rather than impede access to care, in our opinion, clinical adoption of innovative technology and procedures for Medicare beneficiaries has actually been accelerated by generation of such a strong evidence base of performance and outcomes in the TVT Registry.

Continuation of Hospital Program Volume Criteria and Access to Care

Hospital and operator volume requirements are supported by ACC/AHA, STS, AATS, and SCAI consensus documents. Registry and observational studies consistently demonstrate that higher institutional and operator volumes are associated with lower mortality, fewer complications, and improved outcomes after TAVR. For all hospitals and especially lower-volume hospitals, mandatory participation in the TVT Registry is essential for benchmarking and quality improvement. Although we are not convinced that the addition of more low volume TAVR sites will improve any access to care issues, given the clear volume-outcome relationship with TAVR, close monitoring of procedure outcomes in lower-volume programs should be mandatory. Any program with poor outcomes should undergo prompt remediation or closure of the program

Summary

In summary, we support coverage for patients with asymptomatic, severe AS. Furthermore, we recommend that the NCD cover patients with “aortic valve disease with an FDA approved indication” to cover other possible future indications including aortic regurgitation and moderate AS. We also support continuation of CED as this is necessary to assure benefits to patients with asymptomatic AS, as well as other further expanded indications. We also want to stress the importance of maintaining Heart Team care delivery and excellent procedural outcomes and remain concerned about the ability of additional low volume outcomes to maintain both sufficiently.

Martin B. Leon, MD
Michael Mack, MD
For the Heart and Valve Collaboratory

Less

As the Chief Operating Officer at a facility that provides TAVR to the community we serve, I am concerned that the current TAVR National Coverage Determination (NCD) no longer reflects modern clinical practice or the operational realities facing hospitals. The prescriptive evaluation and operator requirements create avoidable delays that increase urgent admissions, strain capacity, and drive higher Medicare spending. TAVR is now a well-established therapy across all surgical-risk categories (Otto et al., Circulation, 2021), yet the NCD’s rigid processes slow access to definitive treatment. Evidence shows that prolonged wait times lead to higher rates of emergent admissions, heart failure decompensation, and pre-procedure mortality (Elbaz-Greener et al., Circulation, 2018; Barbash et al., JACC: Cardiovascular Interventions, 2020). These delays also disrupt hospital throughput and increase resource utilization.

To support timely, efficient care, CMS should update the NCD to allow greater flexibility in both evaluation and operator requirements. In particular, the current mandate for two specialty-specific operators—one interventional cardiologist and one cardiac surgeon—no longer reflects contemporary practice patterns or the evolving skill sets within structural heart programs. While a multidisciplinary process and review may be ideal, with a national workforce shortage projected to intensify across both specialties, maintaining rigid operator requirements risks creating capacity constraints that limit patient access without improving safety or outcomes, particularly in high-risk, diverse communities. Allowing hospitals to meet operator requirements through a broader set of qualified structural heart specialists would preserve procedural quality while enabling programs to adapt to workforce realities.

Similarly, reducing the mandatory dual-specialty evaluation to one qualified specialist would maintain the integrity of the heart team model while providing hospitals the flexibility to design workflows that align with their staffing, expertise, and operational capacity. This flexibility is essential for eliminating bottlenecks that do not contribute to improved quality or safety.

The NCD should also incorporate contemporary evidence supporting early intervention in asymptomatic severe aortic stenosis. The EARLY TAVR randomized trial demonstrated that early TAVR significantly reduced all-cause death, stroke, or unplanned cardiovascular hospitalization compared with surveillance (EARLY TAVR Investigators, NEJM, 2024). Observational data further show that up to one-third of initially asymptomatic patients require urgent hospitalization before receiving definitive therapy (Lindman et al., JACC, 2019). Updating the NCD to reflect these indications would reduce preventable admissions, improve outcomes, and lower total Medicare expenditures. Modernizing the TAVR NCD is critical to ensuring efficient, cost-effective, and equitable care delivery that aligns with current evidence, workforce projections, and the operational demands of today’s cardiovascular programs.

Mike Busky
Chief Operating Officer
Ascension Alexian Brothers

Less

The Medical Device Manufacturers Association (MDMA), a national trade association representing hundreds of primarily small to mid-sized, innovative companies in the field of medical technology, is pleased to provide these comments on CMS’ reconsideration of its National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).

MDMA reiterates our strong support for the CED pathway. We believe that CED represents an appropriate use of the agency’s authority under section 1862(a)(1)(E) of the Social Security Act. The CED pathway is critical to providing timely access for Medicare beneficiaries and their physicians to cutting edge therapies and diagnostics, with appropriate beneficiary protections, and to generating additional clinical evidence sufficient to support future “reasonable and necessary” coverage determinations under section 1862(a)(1)(A). In some cases, it provides an alternative to a finding of noncoverage, which would foreclose access and hamper ongoing development of clinical evidence within the Medicare population.

While recognizing the critical role CED plays in providing access for Medicare beneficiaries and their physicians to the most advanced medical device and diagnostic technologies available for their care, it is also important to acknowledge the concerns that have been raised about how it has been used in particular circumstances—including the significant amount of time that data collection requirements have remained in place for some technologies and the barriers to access and additional costs that data collection requirements themselves can create for patients and providers. The NCD for TAVR has been in place for nearly 14 years and it has been seven years since its last reconsideration. Determining the appropriate duration of coverage under CED is dependent on the particular technology or service, but we note that 14 years is significantly longer than the “approximately five or more years” offered by CMS as a guideline for CED in the final notice for the Transitional Coverage for Emerging Technologies (TCET) program.

Given the long history of the current NCD, we believe that CMS could have provided more guidance to stakeholders on specific questions the agency will be focusing on as part of its review. The agency has been evaluating TAVR for well over a decade and providing additional information to guide stakeholders in providing comment would have been helpful. We hope CMS will keep this feedback in mind when opening NCAs to reconsider other CED coverage policies in the future.

MDMA supports reconsideration of the current NCD, as we believe that adequate evidence has been gathered under Coverage with Evidence Development (CED) to demonstrate that TAVR is “reasonable and necessary” under section 1862(a)(1)(A) of the Social Security Act, at a minimum with regard to the population covered under the existing NCD.

In addition to the removal of CED requirements for symptomatic aortic stenosis patients covered under the existing NCD, we also urge CMS to carefully consider whether current evidence supports coverage of asymptomatic aortic stenosis patients under section 1862(a)(1)(A), consistent with CMS’ principles governing the application of CED—specifically, that “CED will not be used when less restrictive coverage is justified by the available evidence.”

Finally, while we appreciate the value of the data that has been collected from mandating registry participation under the current CED policy, in general we believe that it is inappropriate and potentially outside the scope of the agency’s statutory authority for CMS to mandate ongoing data collection (including registry participation) as a condition of coverage for a procedure that is found to be “reasonable and necessary” under 1861(a)(1)(A). In addition, as part of this reconsideration, we believe CMS should carefully assess whether current facility and practitioner requirements—including requirements related to facility and operator volume— are needed to ensure high quality TAVR outcomes for Medicare beneficiaries and ensure they do not inappropriately limit beneficiary access or impose unnecessary costs or other burdens on providers. To the extent that changes to facility and practitioner requirements raise significant questions regarding clinical outcomes, CMS should analyze and solicit comment on whether further evidence development under section 1861(a)(1)(E) that is specifically focused on those questions is warranted.

Thank you again for the opportunity to provide these initial comments on the TAVR reconsideration.

Sincerely,

Dan Waldmann
EVP, Health Policy & Reimbursement
MDMA

Less

As an Interventional cardiologist, and a structuralist, I am a big advocate of the Heart Team. But also a big advocate of the patient and it is important to have the patient understand the possible options presented by 2 different specialties. Seeing what we have evolved from in PCI this can be applied and continued to be applied in Valvular disease management. The ability to perform these procedures, with 2 qualified, structurally trained physicians is key. Though TEER as an example doesnt require a surgeon to perform, yet the Heart Team harmony in having a surgeon from clinic evaluation to therapy is key to provide a well balanced view of the disease to the patient to continue that journey of valve treatment. Understanding that this may not be attainable in many centers around the country, hence should be left to the centers expertise on procedural involvement of experienced operators.

In addressing aortic valve stenosis, and with the good outcomes of transfemoral TAVI in low risk anatomy, and not hostile ones, approaching this disease early has shown benefit and does make sense. With programs having long wait times, and the ambiguity of valvular symptoms in such age group, aortic stenosis can be deceiving and may delay care leading to acute valve syndrome admissions, worse outcomes and increased healthcare costs.

Continue to maintain registry level data collection, as it is important to provide some degree of reporting to track outcomes in TAVR centers. There should be more scrutiny and connection to medicare data inorder to ensure accuracy of data collection and informative research and publications to further guide the field on trends.

Putting the patient in the center of all of this, The Heart Team is impoprtant at the time of discussion and decision making, especially as we treat younger patients, repeatibility of TAVR vs explanting and performing surgery. The procedure has evolved to be done by either Interventional cardiologists or percutaneously trained surgeons. Severe valvular disease is not benign, and whether we agree or critique the endpoints of the Early TAVR trial, we will arrive to a conclusion one day that severe aortic stenosis is not benign and needs to be addressed earlier, and perhaps may even be too late if waiting to be symptomatic, in affecting patients survival compared to a similar patient with no aortic stenosis.

Less

As an administrator in a large health system, I encourage CMS to modernize the NCD for TAVR. These outdated requirements have created delays in treatment for patients and unfortunately cause harm. There are studies demonstrating how these delays have exacerbated symptoms, cause heart damage, increased hospitalizations, and overall higher mortality prior to the procedure. With this comes more emergent procedures and higher costs for health systems across the country.

I ask CMS to help improve access for patients, reduce costs, and align with evidence by reconsidering the following:

• Expand coverage for asymptomatic aortic stenosis. This is supported by the EARLY TAVR trial.
• Streamline the pre procedural process by allowing consultation by either a cardiac surgeon or an interventional cardiologist. Programs work fearlessly to update their processes to ensure timely care. This is hard to do with outdated expectations.
• Allow hospitals to determine if one or two operators are necessary based on individualized care from the heart team.

These modifications will preserve the necessary step to keep our patients safe, while removing outdated barriers. I appreciate the opportunity to comment on this and hopeful for positive change.

Less

To: Hon. Robert F. Kennedy, Jr., Secretary, US Department of Health and Human Services
Dr. Mehmet Oz, Administrator, Centers for Medicare and Medicaid Services
From: Andrew Langer, Director, Center for Regulatory Freedom
Date: January 14, 2026
Re: Comments to US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) in response to a Request for Comment on a National Coverage Analysis, “Transcatheter Aortic Valve -Replacement,” NCD Publication Number 100-3, Published by CMS on December 15, 2025

Below are comments of the American Conservative Union Foundation's (d/b/a. Conservative Political Action Coalition Foundation) (hereinafter “CPAC Foundation”) Center for Regulatory Freedom (hereinafter “CRF”), in response to US Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) in response to Request for Comment on a National Coverage Analysis, “Transcatheter Aortic Valve -Replacement,” NCD Publication Number 100-3, published by CMS on December 15, 2025.

CRF is a project of the CPAC Foundation, a non-profit, non-partisan 501(c)(3) research and education foundation. Our mission is to inject a common-sense perspective into the regulatory process, to ensure that the risks and costs of regulations are fully based on sound scientific and economic evidence, and to ensure that the voices, interests, and freedoms of Americans, and especially of small businesses, are fully represented in the regulatory process and debates. Finally, we work to ensure that regulatory proposals address real problems, that the proposals serve to ameliorate those problems, and, perhaps most importantly, that those proposals do not, in fact, make public policy problems worse.

Introduction
We submit these comments in response to the Centers for Medicare and Medicaid (CMS) opportunity for public comment on the National Coverage Determinations (NCD) for transcatheter aortic valve replacement (TAVR). In 2012, CMS established Medicare coverage for this technology under Coverage with Evidence Development (CED). In our view, CED is an unnecessary bureaucratic hurdle that wastes time and resources, creating a structural barrier to patient access. We urge CMS to reexamine the use of CED in TAVR coverage determinations and throughout the healthcare system and ultimately remove the program from all health plans except in extreme circumstances.

Evidence Maturity and the Obsolescence of CED for TAVR
When CMS first adopted Coverage with Evidence Development for transcatheter aortic valve replacement in 2012, the agency appropriately sought additional information regarding real-world outcomes, long-term durability, and performance outside tightly controlled clinical trials. More than a decade later, those evidentiary questions have been answered.
CMS’s own National Coverage Determination identifies four core evidence questions underpinning continued CED: (1) whether outcomes outside controlled trials are consistent with pivotal studies; (2) the long-term durability of transcatheter valves; (3) long-term outcomes and adverse events; and (4) patient- and procedure-level factors influencing outcomes. Each of these questions has now been addressed through randomized trials, long-term follow-up, and large-scale national registry experience.

Real-World Outcomes Now Align With—and Often Exceed—Pivotal Trials
Since CMS last substantively reviewed the TAVR NCD, multiple randomized trials have reported five-year outcomes in low-risk patients, demonstrating that transcatheter valve replacement achieves clinical outcomes comparable to surgical valve replacement with respect to all-cause mortality and disabling stroke. These findings are not limited to a single device platform and reflect contemporary practice rather than early-generation technology.
Importantly, these trial findings are reinforced by national registry data capturing real-world Medicare populations. Analyses of the STS/ACC Transcatheter Valve Therapy Registry show that short-term mortality and complication rates have declined steadily over time as operator experience and device technology have improved. These data directly address CMS’s concern about outcomes when TAVR is performed outside controlled clinical trials and demonstrate that real-world performance is consistent with—and in many cases better than—earlier pivotal studies.

Long-Term Durability Is No Longer an Open Question
CMS has appropriately emphasized valve durability as a core justification for continued evidence development. However, long-term durability data are now available. Randomized trials with extended follow-up, including studies reporting outcomes out to eight years, demonstrate no excess structural valve deterioration or valve failure with transcatheter valves compared to surgical alternatives. Echocardiographic performance has remained stable over time, and rates of repeat aortic valve intervention remain low.
These findings substantially resolve the uncertainty that originally justified CED and undermine the premise that continued mandatory registry participation is necessary to answer durability questions for currently approved TAVR indications.

Quality-of-Life and Functional Outcomes Are Well-Established
Beyond survival and procedural safety, TAVR has consistently demonstrated sustained improvements in patient-reported quality of life and functional status. These benefits have been documented in both randomized trials and real-world cohorts and persist well beyond the immediate post-procedure period. For Medicare beneficiaries—many of whom are older and have limited tolerance for invasive surgery—these durable functional gains are particularly relevant.

Continued CED Now Functions as an Access Restriction, Not an Evidence Tool
While CMS originally adopted CED to close evidence gaps, its continued application to TAVR now operates primarily as a structural barrier to care. Requirements tied to registry participation, institutional volume thresholds, and site-of-service restrictions disproportionately affect rural patients and beneficiaries with limited ability to travel to high-volume centers.
Empirical analyses have shown that geographic distance and regional availability significantly influence access to TAVR services, even where clinical eligibility is clear. As a result, Medicare beneficiaries who would otherwise benefit from a safe, effective, and well-established therapy face delays or forego treatment altogether—not because of unresolved scientific uncertainty, but because of administrative conditions unrelated to patient safety or outcomes.

CED is Unnecessary and Duplicative
As an organization committed to defending individual liberty and limiting bureaucratic overreach, we oppose the use of CED in any government-sponsored health plans. CED bases coverage decisions on patient enrollment in approved clinical trials. This occurs despite the fact that the treatments in question, such as TAVR, are already approved by the Food and Drug Administration (FDA). Requiring participation in trials, which often don’t even result in published data, creates a senseless obstacle that disproportionately impacts rural patients and those struggling with mobility issues. Thanks to this policy, patients in desperate need of expedient treatment are often faced with delays and or even denials to coverage.
CMS should, of course, require research showing a treatment is safe and effective before promoting and covering it under sponsored health plans. However, data from over 10 years of TAVR procedures have long since answered CMS’s initial questions about the treatment. Continuing to impose hurdles that patients must navigate to receive coverage for an approved treatment is senseless, cruel, and un-American.

Recommendation
CMS should carefully examine the use of CED in coverage determinations, particularly for life-changing treatments like TAVR. With the necessary evidence suggesting that the procedure is safe and effective in hand, CMS’s continued requirement that patients enroll in trials to receive coverage is unethical, restrictive, and demonstrates government inefficiency at its finest. Across various diseases, policymakers should work to make treatments available as quickly as possible. CED directly works against that goal. To further this Administration’s priorities of cutting through needless red tape and removing unnecessary policies from our government, CMS should remove CED from all coverage determination decisions except in extreme cases involving serious, post-market safety concerns.
America’s seniors deserve a Medicare system that works for them. Bureaucratic restrictions requiring them to jump through hoops to obtain coverage for safe and effective treatments should never be a part of that. CMS has the opportunity to make positive changes by reexamining the use of CED, and the agency has a responsibility to take this step to protect American healthcare.

Sincerely,

Andrew M. Langer
Director
CPAC Foundation Center for Regulatory Freedom

Less

TVT registry should be on a voluntary basis, similar to STS registry, and not mandatory.
Currently, the requirement for the TVT registry are cumbersome and should be streamline.
Test such as 6-min walk test, KCCQ score, and mandatory TTE at 30 days and 1 year represent a massive burden to sites, and limits capacity to assess new patients.
More importantly, the quality of the data is highly questionable, due to the self-reporting nature of the data, with many complications systematically being underreported by sites (i.e stroke, vascular complications, etc.).
One of the most important remaining questions regarding TAVR (and SAVR as well) is related to the valve durability and long term follow-up, which is currently not part of the TVT registry, and will be better assess by long term randomized trial data and other types of registries.
Finally, the evaluation of TAVR and SAVR throughout registries should follow similar standard.

Less

Dear CMS,

Thank you for the opportunity to provide my opinion on the reevaluation of the TAVR NCD. I am a board certified cardiac surgeon and Director of the Structural Heart Program at The Mid-America Heart Institute in Kansas City, Missouri. I’ve been in practice for 24 years and have participated in TAVR since 2008 as an investigator in the Edwards PARTNER Trial. I’m very proud of my involvement in this space and as an active member of our heart team I’ve been involved at the national level on TAVR initiatives involving valve in valve, alternate access, leaflet mitigation to prevent coronary obstruction and TAV in TAV.

The phenomenal success of TAVR and the outstanding data generated to date is the result of a close collaborative relationship between interventional cardiology and cardiac surgery which has promoted the best care pathway for each individual patient. This collaboration has become more, not less important, as we treat lower risk and younger patients with an eye towards lifetime management of their valvular heart disease. As an increasing number of TAVR valves fail the decision on whether SAVR or TAVR should be first is currently the most important question we address in our multidisciplinary valve clinic. In addition, the complexity of the patient, whether it be from needing alternate, non-femoral access or complicated valve in valve or TAV in TAV procedures makes the heart team more important not less.

While I certainly agree that the NCD should be revisited and I also agree that the current volume restraints should be relaxed I am fundamentally opposed to the abolishment of the heart team or moving to one operator. The superb results with our aortic valve patients that are obtained today are based on a model that is neither outdated or dysfunctional and has proven value in the management of these increasingly complicated patients. Revisiting the NCD with the goal of making sweeping changes was not requested by physicians, but is a industry driven endeavor and will not be in the best interest of our Medicare patients.

Keith B. Allen, M.D.
Clinical Associate Professor of Surgery,
University of Missouri at Kansas City
Director of Surgical Research
Co-Director of Structural Heart
St. Luke's Hospital of Kansas City
St. Luke's Mid America Heart Institute
4330 Wornall Road, Suite 50-II
Kansas City, MO 64111
office (816) 931-3312
kallen2340@aol.com

Less

I have performed over 5000 TAVR cases at St.Lukes hospital in Milwaukee, Wisconsin. Based on my experience, I am a strong advocate of the heart team approach and continued close involvement of our surgical colleagues. First and foremost, outcomes will be worse if surgeons are not directly involved and immediately available; complications occur more frequently in the real world compared to clinical trials and the ability to manage these patients together with the help of our surgeons is paramount to maintaining high quality outcomes. Second, structural heart patients are becoming increasingly complex, and we believe we make better decisions for these patients when we include the opinions of a multidisciplinary group of experts, including cardiologists, surgeons, imaging specialists, and heart failure specialists, etc. We should strive as a field to continue to achieve the best outcomes possible for all patients, and as part of that we are strong advocates for the continued monitoring of our patients and their outcomes using the TVT registry.

Tanvir Bajwa, MD
Yuting Chiang, MD
Aurora St Luke's Medical Center
Milwaukee, WI

Less

January 14, 2026

Administrator Mehmet Oz
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: NCA for Transcatheter Aortic Valve Replacement (CAG-00430R2)

Dear Administrator Oz:

On behalf of the Preventive Cardiovascular Nurses Association, thank you for the opportunity to comment on the National Coverage Analysis for Transcatheter Aortic Valve Replacement (CAG-00430R2).
The Preventive Cardiovascular Nurses Association (PCNA) was founded in 1992 by a group of nurses working in cardiovascular disease management and has since expanded into 41 chapters across the United States. PCNA is the leading nursing organization dedicated to preventing and managing cardiovascular disease. Our mission is to promote nurses as leaders in cardiovascular disease prevention and management across the lifespan.

We are writing to support the removal of coverage with evidence development (CED) and other outdated requirements in the current National Coverage Determination (NCD) under Medicare for Transcatheter Aortic Valve Replacement (TAVR).

TAVR is a minimally invasive procedure used to treat aortic stenosis – a serious heart condition characterized by stiff, narrow aortic valves that restrict blood flow – in which a catheter is used to send a replacement valve up to the heart to replace the damaged valve. [1] As an alternative option to open-heart surgery, TAVR has become increasingly utilized as an option for patients who are unable to withstand a traditional surgery. In fact, findings from a recent clinical trial on patients with aortic stenosis who are at intermediate or high risk for death with surgery suggest that TAVR significantly lowers one’s risk of death, stroke, or rehospitalization after one year. [2]

The original NCD under Medicare for TAVR includes qualification requirements for hospital programs and heart teams to establish a TAVR program that can be burdensome for hospitals, particularly those in under-resourced areas. Recommendations from a 2023 roundtable discussion hosted by the Association of Black Cardiologists (ABC) note that the current CED requirements for TAVR under Medicare are outdated and contribute to barriers faced by minority patients eligible for TAVR. [3] Moreover, a 2024 study by the American Heart Association (AHA) revealed lower rates of TAVR utilization in areas with higher levels of socioeconomic deprivation. [4] Retaining the existing CED requirement for TAVR Medicare coverage restricts access to TAVR and risks worse patient outcomes from unnecessary invasive procedures. [5]

In addition to the removal of existing CED requirements, the NCD for TAVR under Medicare should be updated to include patients with asymptomatic aortic stenosis. Recent data suggests that asymptomatic severe aortic stenosis can lead to the progression of symptoms without appropriate intervention. [6] Moreover, a randomized clinical trial study demonstrated significant reductions in the incidence of death, stroke, or unplanned hospitalization for cardiovascular events among patients with asymptomatic severe aortic stenosis who received early TAVR as opposed to clinical surveillance. [7] Growing clinical evidence shows promise for improved patient outcomes if coverage under Medicare for TAVR is updated to include patients with asymptomatic aortic stenosis.

Increased access to TAVR also shows promise to decrease the economic burdens of inpatient hospital care on the broader health care system. According to a report from The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry, increased use of TAVR is associated with a decline in the median length of stay for patients of varying risk from seven days to two days. [8] Researchers also found that over 90 percent of patients in 2019 were discharged home, suggesting favorable outcomes following TAVR without costly, extended hospital stays. [8] Aortic stenosis is a serious, life-threatening condition, but increased access to TAVR can contribute significantly to better patient outcomes and lessen the economic burden on the health care system.

As one of the most highly studied procedures in cardiovascular care, evidence demonstrates the effectiveness and safety of TAVR as a treatment to address aortic stenosis in a variety of patients. [9] By sunsetting CED requirements for TAVR under Medicare, CMS will help advance the cardiovascular community in our goal toward improved patient outcomes by promoting less invasive, highly effective treatment for aortic stenosis in symptomatic and asymptomatic patients, especially among minority communities.

On behalf of patients living with aortic stenosis and the Preventive Cardiovascular Nurses Association, we support the removal of CED and other outdated requirements in the current NCD under Medicare for TAVR.

Sincerely,
Preventive Cardiovascular Nurses Association

Resources:
[1] Lindman, B. R., Alexander, K. P., O'Gara, P. T., & Afilalo, J. (2014). Futility, benefit, and transcatheter aortic valve replacement. JACC. Cardiovascular interventions, 7(7), 707–716. https://doi.org/10.1016/j.jcin.2014.01.167.
[2] Mack, M. J., Leon, M. B., Thourani, V. H., Makkar, R., Kodali, S. K., Russo, M., Kapadia, S. R., Malaisrie, S. C., Cohen, D. J., Pibarot, P., Leipsic, J., Hahn, R. T., Blanke, P., Williams, M. R., McCabe, J. M., Brown, D. L., Babaliaros, V., Goldman, S., Szeto, W. Y., … Smith, C. R. (2019). Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. New England Journal of Medicine, 380(18), 1695–1705. https://doi.org/10.1056/nejmoa1814052.
[3] Association of Black Cardiologists, Inc. (2025). (rep.). Continuing to Address Gaps in Care Among Minority Patients with Valvular Heart Disease. Retrieved January 2, 2026, from https://abcardio.org/continuing-to-address-gaps-in-care-in-minority-patients-with-valvular-heart-disease/.
[4] David, G., Bergman, A., Gunnarsson, C., Ryan, M., Chikermane, S., Thompson, C., & Clancy, S. (2024). Limited access to aortic valve procedures in socioeconomically disadvantaged areas. Journal of the American Heart Association, 13(2). https://doi.org/10.1161/jaha.123.030569.
[5] Association of Black Cardiologists, Inc. (2025). (rep.). Continuing to Address Gaps in Care Among Minority Patients with Valvular Heart Disease. Retrieved January 2, 2026, from https://abcardio.org/continuing-to-address-gaps-in-care-in-minority-patients-with-valvular-heart-disease/.
[6] Song, Q., Liu, R., Yang, K., Tu, X., Tan, H., Fan, C., & Li, X. (2025). Early aortic valve replacement of asymptomatic severe aortic stenosis: A meta-analysis of Randomized Controlled Trials. Journal of the American Heart Association, 14(16). https://doi.org/10.1161/jaha.125.041283.
[7] Généreux, P., Schwartz, A., Oldemeyer, J. B., Pibarot, P., Cohen, D. J., Blanke, P., Lindman, B. R., Babaliaros, V., Fearon, W. F., Daniels, D. V., Chhatriwalla, A. K., Kavinsky, C., Gada, H., Shah, P., Szerlip, M., Dahle, T., Goel, K., O’Neill, W., Sheth, T., … Leon, M. B. (2025). Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. New England Journal of Medicine, 392(3), 217–227. https://doi.org/10.1056/nejmoa2405880.
[8] Carroll, J. D., Mack, M. J., Vemulapalli, S., Herrmann, H. C., Gleason, T. G., Hanzel, G., Deeb, G. M., Thourani, V. H., Cohen, D. J., Desai, N., Kirtane, A. J., Fitzgerald, S., Michaels, J., Krohn, C., Masoudi, F. A., Brindis, R. G., & Bavaria, J. E. (2021). STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. The Annals of Thoracic Surgery, 111(2), 701–722. https://doi.org/10.1016/j.athoracsur.2020.09.002.
[9] Columbia University Irving Medical Center, Department of Surgery. (2019, March 17). A breakthrough in heart valve surgery: More people can now benefit from TAVR procedure. Columbia Surgery. https://columbiasurgery.org/news/2019/03/17/breakthrough-heart-valve-surgery-more-people-can-now-benefit-tavr-procedure.

Less

January 14, 2026

Sarah Fulton, MHS
Lead Analyst, NCA for TAVR (CAG-00430R2)
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Comments on National Coverage Determination (NCD) Reconsideration Request for Transcatheter Aortic Valve Replacement (TAVR) 20.32: Strategic Amendment to Section B to Enable Seamless Coverage Transition for FDA Approved Indications

Dear Ms. Fulton,

I respectfully submits these comments in response to the National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) initiated on December 15, 2025, in response to a formal reconsideration request submitted by Edwards Lifesciences on July 28, 2025. As the developer and manufacturer of the Trilogy™ Heart Valve System, an FDA designated Breakthrough Device and the only TAVR system specifically designed to treat aortic regurgitation (AR, a condition affecting 2.0% of patients aged 75 and older [1]), I have a unique perspective on the evolving landscape of transcatheter aortic valve therapies and the infrastructure necessary to ensure patient access to innovative, lifesaving treatments. JenaValve has three active studies that are covered under Section B of the NCD; the ALIGN-AR Trial, which is currently in a Continued Access Protocol (CAP), the ARTIST Study, and the JENA-VAD Registry.

The Edwards request contains three primary elements: 1) expanding coverage to asymptomatic patients, 2) Coverage with Evidence Development (CED) requirements, and 3) eliminating facility/evaluation requirements. While we support efforts to expand patient access to life saving TAVR therapy, we believe that modification without appropriate safeguards, would compromise patient safety, dismantle critical quality infrastructure, and eliminate essential oversight. In particular, a critical modification that should be made to the NCD is to revise it so that a use that has been covered via an approved study or registry does not lose coverage solely because that use is approved by the FDA, as the current language of Nationally Covered Indication “B” dictates.

A critical historical precedent underscores these concerns: when CMS ended mandatory registry participation for implantable cardioverter defibrillators (ICDs) in February 2018, hospital participation dropped approximately 55%, from over 1,800 hospitals to approximately 800 hospitals in 3 years [2]. This fundamental loss of surveillance infrastructure cannot be replaced by manufacturer conducted FDA post approval studies that focus on limited patients and hospitals and are not representative of underserved, covered beneficiaries [3, 4].

Evidence from Aortic Regurgitation: Clinical evidence demonstrates the critical importance of maintaining CED requirements for emerging indications. The ALIGN-AR pivotal trial (700 patients) of the Trilogy™ Heart Valve System achieved 95% technical success and 7.7% 1-year mortality versus a 25% performance goal (p<0.0001) [8]. In contrast, the PANTHEON registry documented the limitations of off label TAVR for AR: only 83.6% technical success, 12.4% device embolization/migration, and 9.2% residual moderate/severe AR [9]. A meta-analysis of 2,162 patients confirmed dedicated devices achieve superior outcomes: 30-day mortality 3% vs. 9%, device success 93% vs. 82%, and 1-year mortality 6% vs. 24% compared to off label devices [10]. Without CED requirements, Medicare would reimburse off label devices despite inferior outcomes, while manufacturers who invested in indication specific trials would face unfair competition.

JenaValve proposes modification of Section B of the TAVR NCD to enable the coverage with evidence development of uses regardless of an FDA approved indication for the use. That revision will end the perverse result of Medicare having to discontinue coverage under a CMS approved study or registry solely due to the FDA approval of an indication for use.

I. Proposed Amendment to Section B: Seamless Coverage Transition Pathway

JenaValve proposes a strategic amendment to Section B of the TAVR NCD that would establish a clear, predictable pathway for devices that have successfully completed CMS approved clinical studies to transition from Section B coverage to full Section A coverage upon FDA approval. This proposal addresses a specific gap in the current NCD framework that requires repeatedly opening the TAVR NCD when new indications are approved, while preserving quality safeguards.

A. Current Challenge

Under the current NCD structure:

• Section A covers TAVR for the treatment of symptomatic aortic valve stenosis for FDA approved indications with CED requirements including registry participation.
• Section B covers TAVR for uses "that are not expressly listed as an FDA approved indication" when performed within CMS approved clinical studies answering one of seven clinical outcomes questions and meeting specific scientific integrity standards.

The current Section B language creates a problematic cliff: when a device successfully completes Section B clinical studies and subsequently receives FDA approval for a new indication (such as aortic regurgitation), coverage under Section B would terminate because the use is no longer "not expressly listed as an FDA approved indication." However, if Section A does not encompass the newly approved indication, a coverage gap results. While CMS has an established mechanism for expanding coverage following successful CED, namely reconsideration of the NCD, the timing of FDA approval and NCD reconsideration may not align, leaving Medicare beneficiaries without coverage for the FDA approved, purpose built device.

B. Proposed Solution: Automatic Transition Pathway

We propose adding the following language to Section B of the NCD:
PROPOSED LANGUAGE: Section B Amendment
"C. Transition to Section A Coverage for FDA Approved TAVR Devices
When a TAVR device and implantation system that has been covered under Section B of this NCD subsequently receives FDA premarket approval (PMA) for an indication addressed in the CMS approved clinical study:
(1) Coverage shall automatically transition to Section A of this NCD, effective on the date of FDA approval, provided that:
(a) The clinical study has met its primary safety and efficacy endpoints as reported to CMS;
(b) The manufacturer has submitted to CMS documentation of FDA approval and a summary of final clinical study results within 30 days of FDA approval;
(c) The device and implantation system continues to meet all applicable infrastructure, heart team, and facility requirements specified in Section A.
(2) The transitioning device shall participate in the national audited registry specified in Section A, beginning on the date of FDA approval.
(3) CMS will provide written confirmation of transition to Section A coverage within 60 days of receiving complete documentation. During this confirmation period, coverage under Section A shall continue without interruption.
(4) For devices treating indications not currently specified in Section A, Section A coverage criteria shall apply, with the new indication automatically incorporated into Section A upon FDA approval."

II. Rationale and Benefits of the Proposed Amendment

A. Benefits for CMS and the Medicare Program

• Leverages Existing Evidence: Devices covered under Section B have already undergone rigorous CMS review, answering at least 1 of 7 clinical questions and meeting 13 standards of scientific integrity. The clinical studies generate evidence specifically designed to answer CMS relevant questions for the Medicare population.
• Reduces Administrative Burden: An automatic transition mechanism eliminates the need for separate coverage review upon FDA approval, allowing CMS to focus resources on other priorities.
• Maintains Quality Safeguards: The requirement for mandatory registry participation ensures continued monitoring of real world outcomes, consistent with CMS's commitment to evidence based coverage and preserving the surveillance infrastructure that has made TAVR one of the most successful medical technology introductions in cardiovascular medicine.

B. Benefits for Patients

• Eliminates Coverage Gaps: Patients who have been waiting for FDA approval of innovative therapies will have immediate access upon approval, without delays for additional coverage review.
• Ensures Continuity of Care: Providers can confidently plan treatment knowing that coverage will transition seamlessly.
• Addresses Unmet Needs: For patients with conditions like severe AR who currently have no TAVR treatment option, this pathway ensures they can access breakthrough therapies as soon as they are FDA approved.
• Preserves Safety Oversight: Unlike proposals to eliminate CED entirely, this pathway maintains the quality infrastructure and outcome tracking that protects patients, particularly those least represented in clinical trials.

C. Benefits for Industry and Innovation

• Regulatory Predictability: Manufacturers can plan commercialization strategies with confidence, knowing the coverage pathway is clear.
• Incentivizes Innovation: Clear pathways to coverage encourage continued investment in breakthrough technologies that address clinically relevant unmet patient needs.
• Supports Clinical Trial Investment: The assurance of coverage transition rewards manufacturers who invest in high quality clinical studies designed to meet CMS evidentiary standards.
• Creates Level Playing Field: By maintaining CED requirements for off label uses, this approach ensures that manufacturers who invest in indication specific FDA approval are not disadvantaged by unrestricted off label coverage of competing devices.

D. Benefits for the Healthcare System

• Reduces Healthcare Costs: Timely access to less invasive TAVR procedures can reduce complications, hospitalizations, and overall healthcare costs compared to surgical alternatives or medical management alone.
• Supports Value Based Care: Evidence driven coverage decisions aligned with FDA approval support the transition to value based healthcare.
• Preserves Quality Infrastructure: The TVT Registry has documented 30-day mortality decline from 7.6% (2011-2013) to 2.3% (2019) through continuous registry feedback [5, 6]. This infrastructure must be preserved.
• Aligns with International Best Practices: The UK’s National Institute for Health and Care Excellence (NICE) recently concluded that comprehensive registry data is essential for evaluating the comparative value of TAVR devices, explicitly identifying the UK TAVI Registry as the mechanism for future health technology assessments [19]. This international precedent validates CMS’s registry based approach to evidence development and underscores the global recognition that mandatory registry participation is fundamental to informed coverage decisions.

III. Position on Reconsideration Requests

JenaValve provides the following assessment of the three primary elements of the Edwards reconsideration request:

A. Expansion to Asymptomatic Patients: Conditional Support

We acknowledge that the FDA approved the SAPIEN 3 platform for asymptomatic severe aortic stenosis in May 2025, based on the EARLY TAVR trial [7]. We respectfully note critical considerations:

• We support expansion of coverage. Nevertheless, with TAVR now indicated for patients before symptom onset, registry participation is even more critical to monitor real world outcomes in this earlier stage population. Removal of CED requirements would eliminate evidence generation precisely when it is most needed in a newly expanded indication

Recommendation: If CMS determines that coverage expansion to asymptomatic patients is appropriate, we strongly urge that registry requirements are maintained.

B. Removal of CED Requirements: Oppose Complete Elimination

We have concern that the complete removal of CED requirements would diminish TVT Registry participation and data quality and would remove the CMS study requirement for off label TAVR.

The ICD Registry Precedent: Historical evidence demonstrates the consequences of removing mandatory registry participation. When CMS ended mandatory participation for ICDs in February 2018, hospital participation decreased by 55% by 2021 [2]. This represents a fundamental loss of valuable surveillance infrastructure. Why FDA Post-Approval Studies Cannot Replace Mandatory Registries: FDA post-approval studies and CMS mandated registries serve fundamentally different purposes and cannot be treated as interchangeable surveillance mechanisms [3, 4]:

• Population Studied: Registries capture all patients undergoing these procedures at participating hospitals, but FDA studies typically enroll median 350 patients at selected sites with specific inclusion criteria [3]
• Completion Rate: Registries achieve near universal compliance when tied to Medicare reimbursement; only 18% of conditionally approved devices completed FDA post-approval studies 5 years after approval, and FDA has never issued a penalty [3, 4]
• Continuous Quality Improvement that Reflects Changing Practice: Registries were created for just this purpose. To evaluate the effect of indication expansion and provide continuous feedback. By contrast, FDA studies provide a single report at completion reflecting a single practice period. [5, 6]
• Evidence Development: The TVT Registry has generated over 500 peer reviewed publications, the largest source of real world cardiovascular data; FDA study data remains proprietary with limited public availability [5] Impact on Emerging Indications: Removing the CMS study requirement for off label uses would:
• Allow Medicare reimbursement for off label uses without evidence generation to evaluate the utility of such practice. This would allow devices designed for one indication to be used for other conditions without any requirement to report on safety or efficacy.
• Leave emerging indications (e.g. moderate AS, aortic regurgitation, bicuspid valve disease, and patients under 65) without systematic outcomes tracking
• Reduce the need for medical device innovation. Manufacturers would be disincentivized to pursue expensive FDA approval for specific indications through rigorous clinical trials which would foster off label use of devices never tested or approved for those conditions.
• Undermine the ability to demonstrate the value of purpose-built therapies. For indications currently addressed through off label use, CED requirements generate the comparative outcomes data essential to establish whether emerging dedicated devices offer meaningful clinical advantages. Without this evidence framework, manufacturers developing indication specific therapies would lack the datasets necessary to demonstrate superiority over off label alternatives.

Recommendation: CMS should continue mandatory TVT Registry participation regardless of CED status and maintain the CMS study requirement for uses beyond FDA approved indications to preserve quality and the evidence generation framework.

C. Facility and Evaluation Requirements: Maintain with Flexibility

We have concerns about eliminating facility, volume, and evaluation requirements without appropriate safeguards. Mandatory Surgeon Evaluation: The current NCD requirement for evaluation by a cardiac surgeon ensures that patients receive appropriate assessment of whether TAVR, surgical aortic valve replacement (SAVR), or medical management is the optimal treatment pathway. This multidisciplinary Heart Team approach reflects ACC/AHA Class I recommendations. Removing mandatory surgeon evaluation would:

• Eliminate the independent clinical assessment that identifies patients better suited for surgical intervention
• Abandon the shared decision making model central to TAVR's safety record
• Deprive the vast majority of AS patients, those at low and intermediate surgical risk who comprise approximately 80% and 14% of surgical candidates respectively according to STS registry data [11], and for whom surgical guidelines recommend SAVR as the standard of care, of informed access to SAVR, which offers 30-day mortality of 1.0 to 1.4% and 5-year survival exceeding 93% in low risk patients [12]
• Result in patients receiving the treatment of the specialty they are referred to, rather than the treatment most clinically appropriate for their condition Heart Team Evaluation: The 2021 ESC/EACTS Guidelines explicitly warn that "it is no longer appropriate for referring physicians to send patients directly to their preferred surgeon or cardiologist" given the complexity of treatment decisions and the need for multidisciplinary evaluation [13]. The Heart Team requirement exists precisely to ensure that clinical appropriateness, rather than referral patterns, determines patient care.

Volume Thresholds: Substantial evidence demonstrates a volume outcome relationship in structural heart procedures. Vemulapalli et al. (NEJM 2019) found low volume centers had 3.19% vs. 2.66% 30-day mortality, a 20% relative increase in risk [14]. Current geographic access data do not support claims of inadequate availability: Marquis-Gravel et al. (JAMA Cardiology 2020) found median driving time was 35 minutes (IQR: 20 to 70 minutes), and 92.1% of the U.S. population aged 65+ lived in a hospital referral region with a TAVR center [6].

Surgical Backup: The requirement for cardiac surgery capability on site exists because TAVR complications, including annular rupture, coronary obstruction, and severe paravalvular leak, may require emergent surgical intervention. While such complications are infrequent, they can be fatal without immediate surgical capability. Recommendation: Maintain surgical evaluation with Heart Team flexibility, supporting telehealth options for surgeon evaluation when in person assessment is not feasible. Maintain evidence based volume thresholds for TAVR sites with periodic review as technology and evidence evolve. We recommend STS, ACC, SCAI, and ASE collaborate with CMS to establish appropriate thresholds based on current evidence.

IV. Additional Considerations for NCD Reconsideration

History demonstrates the critical importance of robust post-market surveillance:

• Sprint Fidelis Lead Recall (2007): The Medtronic Sprint Fidelis ICD lead was recalled after post-market data revealed fracture rates reaching 2.3% at 30 months, with failure rates increasing to over 15% at 5 years [15, 16]. Without robust post-market surveillance, this safety signal would have been detected later, with more patient harm.
• Metal-on-Metal Hip Implants: The DePuy ASR hip system was recalled in 2010 after international registries with mandatory participation identified 13% failure rates at 5 years, problems that U.S. surveillance missed [17, 18].
• UK NICE TAVI Late Stage Assessment (2025): International experience reinforces the critical importance of mandatory registry infrastructure. In August 2025, the United Kingdom’s National Institute for Health and Care Excellence (NICE) completed a Late Stage Assessment of transcatheter heart valves (HTG757) and concluded that it could not determine whether price variations between different TAVI devices were justified by differences in clinical performance—specifically because the available evidence lacked head to head comparative data between devices. The clinical trial evidence consisted primarily of comparisons between TAVI and surgical valve replacement, not between different TAVI valves. NICE explicitly identified the UK TAVI Registry, managed by the National Institute for Cardiovascular Outcomes Research (NICOR), as the mechanism to address this evidence gap for future assessments [19]. This international precedent demonstrates that without comprehensive registry participation, health technology assessment bodies cannot make informed decisions about the comparative value of different TAVR devices. The UK’s experience validates CMS’s wisdom in establishing mandatory TVT Registry participation and underscores why this requirement must be preserved.

These precedents—both domestic and international—underscore why mandatory registry participation must be preserved as TAVR expands to new indications and patient populations.

V. Summary of Recommendations

JenaValve respectfully urges CMS to:

1. Adopt the proposed Section B amendment: Establish an automatic transition pathway from Section B to Section A coverage upon FDA approval for devices that have successfully completed CMS approved clinical studies, maintaining registry participation and all quality safeguards.
2. Expand the NCD scope: Encompass all TAVR indications, including aortic regurgitation, under a unified coverage framework that maintains quality requirements.
3. Support expansion to asymptomatic AS patients with maintained oversight: If CMS determines that coverage expansion to asymptomatic patients is appropriate based on the EARLY TAVR evidence, such expansion should be accompanied by maintained, not eliminated, registry requirements and quality oversight.
4. Continue mandatory TVT Registry participation regardless of CED status: The ICD Registry precedent demonstrates the consequences of removing mandatory participation, a 55% collapse in hospital participation. Registry infrastructure must be preserved to maintain national outcomes tracking and quality improvement.
5. Maintain the CMS study requirement for off label uses: Continue requiring that TAVR procedures for uses not expressly listed as FDA approved indications be performed in CMS approved clinical studies to preserve evidence generation and prevent unfair competition between indication specific approved devices and off label use.
6. Maintain mandatory surgeon evaluation requirements: Preserve the multidisciplinary Heart Team approach that ensures patients receive appropriate treatment pathway assessment, consistent with ACC/AHA Class I recommendations.
7. Maintain evidence based volume thresholds with periodic review: Ensure procedural competency and optimal patient outcomes. We recommend STS, ACC, SCAI, and ASE collaborate with CMS to establish appropriate thresholds based on current evidence, including the Vemulapalli et al. (2019) NEJM volume outcome study.
8. Maintain surgical backup with Heart Team flexibility: Preserve the safety net for life threatening complications, while supporting telehealth options for surgeon evaluation when in person assessment is not feasible.

VI. Conclusion

The TAVR NCD has successfully balanced patient access with quality and safety through thoughtful requirements for facility capabilities, operator experience, multidisciplinary evaluation, and outcomes tracking. The TVT Registry has documented remarkable improvements in TAVR outcomes, with 30-day mortality declining from 7.6% (2011-2013) to 2.3% (2019) [5, 6]. This infrastructure must be preserved as TAVR expands to new indications and patient populations.

JenaValve’s proposed Section B amendment offers a balanced path forward that addresses the legitimate need for streamlined coverage pathways while preserving essential quality safeguards. The clinical evidence from aortic regurgitation demonstrates why this approach matters: the ALIGN-AR trial achieved 95% technical success with purpose-built devices [8], while off label use of AS designed devices yields markedly inferior outcomes [9, 10]. Maintaining CED requirements for off label uses ensures that patients receive devices specifically designed, tested, and approved for their condition.

The ICD Registry precedent, with its 55% collapse in hospital participation after CMS ended mandatory requirements [2], demonstrates that these concerns are not theoretical. The proposed Section B amendment would:

• Ensure timely patient access to breakthrough therapies through seamless coverage transition upon FDA approval
• Preserve mandatory registry participation essential to TAVR’s continued safety record
• Maintain CMS study requirements for off label uses to ensure evidence generation for emerging indications
• Create a level playing field that rewards investment in indication specific clinical trials and FDA approval
• Eliminate the need for CMS to reopen the TAVR NCD each time a new indication receives FDA approval

I urge CMS to adopt the proposed Section B amendment and to preserve the quality infrastructure that has made TAVR one of the most successful medical technology introductions in cardiovascular medicine. We remain committed to working with CMS to ensure that Medicare beneficiaries have access to safe, effective, and innovative TAVR therapies.

Thank you for the opportunity to provide these comments.

Respectfully submitted,

Jorge Alvarez
Structural Heart Program - Director
Methodist Hospital San Antonio TX

References
[1] Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-1011.
[2] Masoudi FA, Oetgen WJ. The NCDR ICD Registry: A Foundation for Quality Improvement. J Am Coll Cardiol. 2017;70(14):1792-1794. (Documents >1,800 hospitals participating before CMS mandate ended); American College of Cardiology. “ACC Launches NCDR EP Device Implant Registry.” Press Release, April 2, 2021. Available at: https://www.acc.org/about-acc/press-releases/2021/04/02/13/24/acc-launches-ncdr-ep-device-implant-registry. (Documents ~800 hospitals participating after mandate ended.)
[3] Rajan PV, Kramer DB, Kesselheim AS. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies. JAMA Intern Med. 2015;175(11):1773-1779.
[4] Resnic FS, Normand SL. Drugs, devices, and the FDA: Part 2: An overview of approval processes. Circulation. 2018;138(12):e218-e229.
[5] Carroll JD, Mack MJ, Vemulapalli S, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020;76(21):2492-2516.
[6] Marquis-Gravel G, Stebbins A, Kosinski AS, et al. Geographic Access to Transcatheter Aortic Valve Replacement Centers in the United States. JAMA Cardiol. 2020;5(9):1006-1010.
[7] Généreux P, Schwartz A, Oldemeyer JB, et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2024;392:217-227. (EARLY TAVR Trial)
[8] Makkar RR, et al. TAVR With JenaValve for Symptomatic Aortic Regurgitation in High Surgical Risk Patients: ALIGN-AR Trial Results. Presented at ACC.25, Chicago, March 30, 2025. [Lancet publication anticipated]
[9] Poletti E, De Backer O, Scotti A, et al. Transcatheter aortic valve replacement for pure native aortic valve regurgitation: The PANTHEON International Project. JACC Cardiovasc Interv. 2023;16(16):1974-1985.
[10] Samimi S, Hatab T, Kharsa C, et al. Meta-Analysis of Dedicated vs Off-Label Transcatheter Devices for Native Aortic Regurgitation. JACC Cardiovasc Interv. 2024 (published online November 20, 2024).
[11] O’Brien SM, Shahian DM, Filardo G, et al. The Society of Thoracic Surgeons 2008 Cardiac Surgery Risk Models: Part 2, Isolated Valve Surgery. Ann Thorac Surg. 2009;88(1 Suppl):S23-42. (STS database analysis showing 79.9% of SAVR patients were low risk [STS-PROM <4%] and 13.9% were intermediate risk [STS-PROM 4-8%], with only 6.2% at high risk.)
[12] Thourani VH, Suri RM, Gunter RL, et al. Survival After Surgical Aortic Valve Replacement in Low-Risk Patients: A Contemporary Trial Benchmark. Ann Thorac Surg. 2023;117(1):93-102.
[13] Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022;43(7):561-632.
[14] Vemulapalli S, Carroll JD, Mack MJ, et al. Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. N Engl J Med. 2019;380(26):2541-2550.
[15] Hauser RG, Hayes DL. Increasing hazard of Sprint Fidelis implantable cardioverter-defibrillator lead failure. Heart Rhythm. 2009;6(5):605-610.
[16] FDA Class I Device Recall: Medtronic Sprint Fidelis Lead. October 2007.
[17] 2010 DePuy Hip Replacement Recall. Data from UK National Joint Registry showed 13% failure rate at 5 years for ASR XL Acetabular system.
[18] FDA. Concerns about Metal-on-Metal Hip Implants. Updated 2024. Australian Orthopaedic Association Registry identified problems before U.S. detection.
[19] National Institute for Health and Care Excellence (NICE). Transcatheter heart valves for transcatheter aortic valve implantation to treat aortic stenosis: late-stage assessment (HTG757). Published August 21, 2025. Available at: https://www.nice.org.uk/guidance/htg757. Heart Valve Voice. Statement on NICE Late-Stage Assessment Guidance for Transcatheter Aortic Valves. August 22, 2025 (noting that “Strengthening real-world evidence, particularly through the UK TAVI Registry, will be critical to future evaluations”).

Less

January 14, 2026

Administrator Mehmet Oz
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Oz,

On behalf of Heart Valve Voice US (HVV-US), a national non-profit patient advocacy organization dedicated to enhancing the lives of individuals affected by heart valve disease, we appreciate the opportunity to comment on the National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR). As a patient-centered organization, HVV-US brings a unique perspective informed by patients’ lived experiences with heart valve disease and the promise that breakthrough technologies provide. We respectfully urge CMS to update the TAVR National Coverage Determination (NCD) to align with the strength of current clinical evidence, contemporary standards of care, and the urgent need to ensure Medicare beneficiaries with aortic stenosis (AS) have fair and timely access to treatment for this life-threatening condition.

The need for change is reflected in the experience of one of our advocates, Kim, who was diagnosed at birth with Tetralogy of Fallot, a congenital heart condition. She underwent her first surgery at just three weeks old, when a shunt was implanted to help her survive until she could undergo open-heart surgery. At age five, Kim had open-heart surgery that corrected her Tetralogy of Fallot symptoms.

During her junior year of high school, a routine checkup revealed an abnormal echocardiogram. Physicians determined that her heart valve was leaking and required repair, leading to a second open-heart surgery in which a human valve was implanted.

Decades later, in 2019, Kim began experiencing symptoms again, including shortness of breath and significant fluid retention in her legs. After years without regular cardiology care, she decided to see a cardiologist. At the time, she was told her valve was still functioning but leaking and would eventually need to be replaced.

Learning about TAVR changed Kim’s perspective and ultimately her life. Unlike open-heart surgery, TAVR offered a less invasive option, giving her and her doctors the confidence to move forward with treatment. By the time she decided to proceed, her condition had significantly worsened and she could barely breathe. Knowing she could not wait any longer, Kim underwent TAVR in March 2023.

Kim’s experience illustrates why TAVR coverage should extend to appropriately selected patients with initially asymptomatic AS. Under current policy, patients are often required to wait until symptoms significantly impair quality of life before qualifying for intervention. This approach allows disease progression that could be mitigated through earlier, evidence-based treatment and places unnecessary physical and emotional burdens on patients. Patients should not be required to wait for an initially asymptomatic condition to worsen into a symptomatic one, or for their quality of life to decline, before qualifying for intervention.

When Kim learned about TAVR, she finally had a viable alternative. The results of her procedure were immediate and profound. Her excess fluid resolved, color returned to her face, and she felt “uplifted and light.” Within a week, Kim was able to travel internationally and fully resume her active life. Her outcome, along with those of hundreds of other patients, demonstrates that TAVR is a proven and effective therapy and no longer warrants continued Coverage with Evidence Development (CED). Maintaining CED imposes administrative burdens that restrict patient access, limit provider participation, and slow the expansion of care where it is needed most.

We also encourage CMS to remove outdated procedural requirements within the NCD, including rigid specifications regarding staffing and operator roles. These mandates reflect early-stage implementation rather than modern, team-based clinical practice and may unnecessarily limit where TAVR can be offered and who can receive it. Decisions regarding procedural staffing should be left to hospitals and qualified heart teams, whose clinical judgment and experience are best suited to meet individual patient needs while maintaining high standards of safety and quality. While Kim received care from an experienced heart team at a Center of Excellence in Georgia, many patients do not live near hospitals that can meet the NCD’s prescriptive requirements, creating inequitable access to care.

Patients should not have to wait for their health to deteriorate before accessing a life-saving therapy. By expanding indications, sunsetting CED, and removing outdated barriers, CMS can align the TAVR NCD with current evidence and ensure Medicare beneficiaries receive timely, high-quality care regardless of where they live.

In conclusion, we strongly encourage CMS to modernize the TAVR NCD by expanding indications, sunsetting CED requirements, and removing outdated barriers to access. As Kim’s story illustrates, timely, minimally invasive treatment allows patients with heart valve disease to continue living robust, full lives. Aligning coverage with current evidence will promote equity and ensure access to life-saving care for Medicare beneficiaries nationwide.

We appreciate the opportunity to provide these comments and look forward to continued collaboration with CMS to advance patient-centered, equitable coverage policies. Thank you for your consideration of this important issue.

Sincerely,
Berkeley Barnett
Director of Policy & Advocacy
Heart Valve Voice US

Less

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Centers for Medicare and & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-0430R2)

Dear Ms. Baldwin,

Boston Scientific Corporation (BSC) is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We develop and supply medical devices in numerous clinical areas, including cardiology, which serve the needs of many patients, including Medicare beneficiaries.

We appreciate the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) and support reconsideration of the current TAVR National Coverage Determination (NCD).

TAVR has been covered through Coverage with Evidence Development (CED) NCD since 2012. Boston Scientific supports removal or modification of CED requirements when, based on clinical evidence, CMS’s initial uncertainty about whether the item or service is reasonable and necessary in the Medicare population has been substantively resolved. CED is intended to address specific, articulated evidence gaps; however, evidence generation rarely unfolds in a linear or uniform manner. Some CED criteria may be satisfied earlier or more conclusively than others, or CED criteria may become less relevant to CMS’s ability to make a coverage determination as the evidence base matures. We encourage CMS to take a flexible approach that allows assessment of whether the underlying policy questions have been resolved, even when the evidentiary pathway differs from what was originally anticipated, and that prioritizes substantive evidence sufficiency over completeness.

In the case of TAVR, Boston Scientific believes that the CED questions articulated by CMS in the 2019 reconsideration of the TAVR NCD (CAG-00430R) have been adequately answered by data published from the TVT registry,[1] which includes analysis of greater than 275 thousand TAVR procedures, as well as evidence assessed by the 2020 ACC/AHA guideline for the management of patients with valvular heart disease.[2] The current evidence base also supports TAVR procedures as reasonable and necessary for patients with symptomatic aortic stenosis as recommended in the 2020 ACC/AHA guidelines. We therefore support removal of CED requirements for Medicare coverage of TAVR in patients with symptomatic aortic stenosis.

Boston Scientific further recommends that CMS revise the hospital and heart team procedure volume requirements in the current TAVR NCD (20.32) that may limit access to care and create geographic disparities, particularly in rural areas of the United States where there is a severe shortage of specialists. According to the Association of American Medical Colleges, “there were nearly 7 times as many active cardiologists and anesthesiologists...in urban areas than in rural areas in 2022.”[3] Given the availability of a National Quality Forum-endorsed 30-day composite quality measure for TAVR,[4] Boston Scientific believes it would be appropriate to sunset the facility and volume requirements that, to this point, have served as a surrogate measure of TAVR care quality.

Sincerely,
Liesl Hargens
Vice-President, Global Health Economics and Market Access

[1] Carroll, J.D., et al., STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. Ann Thorac Surg, 2021. 111(2): p. 701-722.

[2] Otto, C.M., et al., 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 2021. 143(5): p. e72-e227.

[3] Rethinking Rural Health | AAMC, https://www.aamc.org/about-us/mission-areas/health-care/rethinking-rural-health#:~:text=The%20differences%20in%20the%20number,and%20gynecology%20(Figure%202)

[4] Cardiovascular, Spring 2021 Cycle: CDP Report, https://digitalassets.jointcommission.org/api/public/content/2ab3e5f1395440c88671859cb7b62a8d?v=cb4c901f

Less

January 14, 2026
Centers for Medicare & Medicaid Services (CMS)
Coverage and Analysis Group (CAG)
7500 Security Boulevard
Baltimore, MD 21244
VIA ELECTRONIC MAIL TO: CAGInquiries@cms.hhs.gov

Ms. Joanna Baldwin & Ms. Nina Arya,

Edwards Lifesciences commends CMS’s prioritization of the reconsideration request for the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). We are grateful for your responsiveness to the evolving needs of Medicare beneficiaries with aortic stenosis (AS). The posting of this tracking sheet marks a critical step toward ensuring timely, equitable access to lifesaving AS treatment for Medicare beneficiaries.

Over the past two decades, AS management has undergone a dramatic transformation- from a condition with limited evidence to one of the most rigorously studied areas in cardiovascular medicine. We appreciate the opportunity to comment, and Edwards believes that a future NCD policy should respond to AS patients' needs, anticipate the future needs of AS patients, and support evolving care delivery systems.

The recommendations in our full comment are focused on these key priorities:

• Aligning TAVR coverage with approved FDA indications, including asymptomatic AS.
• Recognizing that TAVR is a reasonable and necessary procedure for AS that has satisfied its Coverage with Evidence Development (CED) requirements, while continuing to support contemporary engagement with national registries as an ongoing cornerstone of quality and transparency.
• Preserving and supporting the critical importance of the multidisciplinary Heart Team (including an interventional cardiologist and cardiac surgeon), while permitting flexibility to address evolving models of treatment for AS patients.

Edwards believes updating this NCD will not only advance care, but will also improve patient outcomes, provide equitable access for all patients with AS, and reduce long-term Medicare costs.

Thank you for consideration of our comments.

Daniel J. Lippis
Corporate Vice President, Transcatheter Aortic Valve Replacement
Edwards Lifesciences

Download full comment.

Less

January 14, 2026

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2)

Dear Ms. Baldwin,
On behalf of the MedTech Association (AdvaMed), we appreciate the opportunity to submit comments on the National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2). AdvaMed and the Centers for Medicare & Medicaid Services (CMS) share a common goal – ensuring timely access for Medicare beneficiaries to clinically appropriate, innovative technologies based on scientifically sound clinical evidence.

AdvaMed member companies develop and produce a wide range of medical devices, diagnostic tests, and digital health solutions that transform care through earlier detection, less invasive approaches, and more effective disease management. Our members, large and small, are united in their commitment to improving patient outcomes and ensuring Medicare beneficiaries have access to lifesaving and life-enhancing technologies.

Support for NCA Initiation and Evidence-Based Coverage Expansion

We commend CMS for initiating this reconsideration of the TAVR National Coverage Determination (NCD) and support the agency's stated focus on coverage of TAVR for aortic stenosis in both symptomatic and asymptomatic patients. We support CMS's commitment to ensuring coverage decisions reflect the current state of clinical evidence, including clinical guidelines and emerging evidence from randomized and real-world studies.

High-quality clinical evidence that appropriately reflects the Medicare population provides the foundation for coverage policies. Updates to covered indications must be driven by comprehensive evidence, long term patient risk-benefit, and professional consensus. Patient access and advancement in indications dually benefit from trials that are rigorous and representative in their design and execution.

Broader Policy Considerations

Beyond the specific issues raised above, several broader policy considerations warrant attention regarding their impact on the national coverage determination process.

NCD Reconsideration Process and Keeping Pace with Innovation:
We are encouraged by CMS's timely initiation of the TAVR NCD reconsideration. This demonstrates the agency's commitment to ensuring that coverage policy reflects current clinical standards and FDA regulatory status. However, we remain concerned about the broader NCD reconsideration process. Many NCDs have not kept pace with innovation, nor do they reflect current regulatory status or clinical evidence. As indicated by the NCD Dashboard [1], some reconsideration requests have been pending for years, creating uncertainty for stakeholders and potentially delaying beneficiary access to beneficial technologies. We encourage CMS to review and modernize its process for managing the NCD reconsideration request waitlist to support more timely and efficient policy updates. In many instances, requested changes may not require a full national coverage analysis but could be addressed through targeted revisions informed by new evidence, updated clinical standards, and regulatory authorizations.

A recent Government Accountability Office (GAO) report found challenges related to varied frequencies of CMS's communication to stakeholders about the status of their NCD requests and a lack of transparency about the criteria the agency uses to prioritize such requests.[2] We encourage CMS to continue its efforts to modernize the NCD reconsideration process, including establishing clearer prioritization criteria and improving communication with stakeholders. We request CMS also address other reconsideration requests that have been pending for some time, ensuring the pace of policy updates matches the pace of innovation. We welcome the opportunity to work collaboratively with CMS on identifying process enhancements that could reduce the time required for evidence-based coverage decisions while maintaining appropriate standards.

Building Flexibility into the NCD Framework:
As CMS works to update the TAVR NCD, we encourage the agency to ensure that this and other NCD updates incorporate sufficient flexibility to accommodate evolving clinical evidence, patterns of care delivery, and expanded indications. An operative NCD framework that can adapt to emerging evidence would advance the shared goal of ensuring appropriate access to technologies important to Medicare beneficiaries, such as TAVR among patients with aortic stenosis, while minimizing the likelihood that CMS would need to reopen NCDs in the near future.

Coverage with Evidence Development (CED):
AdvaMed supports CMS's judicious use of Coverage with Evidence Development (CED) as a pathway to gather additional evidence while providing beneficiary access to promising technologies. However, we believe it is equally important to establish clear criteria and timelines to sunset CED once sufficient evidence has been granted. Evidence generation rarely unfolds in a linear or uniform manner; some CED criteria may be satisfied earlier or more conclusively than others, or CED criteria may become less relevant to CMS’s ability to make a coverage determination as the evidence base matures. We encourage CMS to articulate transparent standards for sunsetting CED which would allow for timely recognition of established evidence, thereby supporting both beneficiary access and continued innovation.

We look forward to continuing to work with CMS throughout this process. If you have any questions regarding these comments or require additional information, please contact me at tburke@advamed.org.

Sincerely,
Tara L. Burke, PhD
Vice President, Payment & Healthcare Delivery Policy
AdvaMed

References:
1. National Coverage Determination Dashboard. Centers for Medicare & Medicaid. September 2025 https://www.cms.gov/files/document/ncddashboard2025.pdf (Accessed January 7, 2026)
2. “Medicare: National Coverage Determinations Are Generally Timely, but Improvements Are Needed.” Medicare: | U.S. GAO, September 9, 2025. https://www.gao.gov/products/gao-25-107623.

Less

Current program requirements should at a minimum, remain the same. Thought should be given to potentially increase the minimum requirement of AVR and/or TAVR for an institution to avoid having a TAVR program on every corner. Current minimums border on too low of procedural volume for a center to have the expertise to sufficiently provide TAVR as a service to patients.

More data is needed prior to FDA approval of TAVR for asymptomatic patients. It should not be based on a single clinical trial. Furthermore, the positive findings of the early TAVR trial were mainly driven by "soft" end point such as hospitalization or what has been coined "acute valve syndrome.'' In clinical practice, active surveillance likely still has a role given the slowly progressive nature of AS. Active surveillance may be adequate for many patients, particularly those younger patients who have to think about "lifetime" management of their valve disease and in which we are seeking as much time which each valve a possible to avoid excess valve procedures in the future.

Less

January 9, 2026

Sarah Fulton, MHS
Joseph Hutter, MD, MA
Coverage and Analysis Group Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Public Comment for NCD for Transcatheter Aortic Valve Replacement

Dear Ms. Fulton and Dr. Hutter,

Henry Ford Health’s Structural Heart program in Detroit, Michigan would like to formally file a comment to support expanding access to Transcatheter Aortic Valve Replacement (TAVR) for patients with severe aortic stenosis (AS), including both symptomatic and asymptomatic individuals.

The EARLY TAVR prospective randomized trial (Evaluation of TAVR Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis) supports the benefit of TAVR in asymptomatic severe aortic stenosis patients, in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes. (Funded by Edwards Lifesciences; EARLY TAVR ClinicalTrials.gov number, NCT03042104) One third of patients in the surveillance arm were hospitalized with significant symptoms of heart failure. The trial also showed that integrated measures of left ventricular and left atrial health at 2-year follow-up were better with early TAVR than with clinical surveillance.

Despite this compelling evidence, insurance companies will not approve the procedure for asymptomatic patients until the NCD is expanded. Unfortunately, this means that some patients will inevitably suffer increased morbidity, unpredictable hospitalizations, as well as the psychological impact of a deadly disease for which they must wait to be treated. We strongly support the expansion of the NCD to include those patients with severe aortic stenosis who are asymptomatic. We believe the physician and patient should have the discretion to make an individualized and patient-centered decision for when TAVR in the asymptomatic patient is the best course of action.

We remain steadfast in our belief that the collaborative 'Heart Team' model—uniting the expertise of structural heart interventional cardiologists and cardiac surgeons—is the gold standard for ensuring optimal patient outcomes in TAVR. However, we believe certain existing mandates now pose a disproportionate burden on the very patients they were intended to protect. Specifically, the requirement for independent face-to-face evaluations by both a surgeon and an interventionalist is increasingly onerous for our elderly patient population, who often struggle with limited mobility and significant travel distances. We support the current collaboration between IC’s and CT surgeons such that both evaluate the patient and partake in the Heart team meeting but we believe that one of the two visits be permissible via video visit.

Thank you,
Tiberio Frisoli, MD
Brian O’Neill, MD
Pedro Villablanca, MD
Pedro Engel, MD
Lisa Okonkowski, BSN, RN
Henry Ford Health System
Center for Structural Heart Disease

Less

Re: Public Comment on National Coverage Analysis (NCAID 321) for Transcatheter Aortic Valve Replacement (TAVR)

On behalf of the Association for Black Cardiologists (ABC) we write to express strong support for the reconsideration of the National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR) to (1) expand coverage to include appropriately selected asymptomatic patients with severe aortic stenosis, and (2) remove the Coverage with Evidence Development (CED) requirements that currently condition Medicare coverage of TAVR.

About ABC
Since our founding 50 years ago, the Association of Black Cardiologists strives to promote the prevention and treatment of cardiovascular disease in Black and minority communities by eliminating gaps in our healthcare system. We work to close these gaps through advocacy that speaks to the inconsistent care in medicine, by promoting minority participation in clinical research, by supporting patient access and adherence to guideline directed medical therapies, and by combating barriers to using existing and emerging technologies.

ABC Comments on TAVR NCD

Support for Expansion to Asymptomatic Patients

Severe aortic stenosis is a progressive and life-threatening condition; delays in intervention are associated with increased morbidity and mortality once symptoms develop. Currently there are no pharmacologic remedies for severe aortic stenosis and if left untreated death typically occurs within months of symptom onset. Emerging evidence supports earlier intervention in appropriately selected and carefully screened asymptomatic patients to prevent irreversible heart damage and avoid acute decompensation. Importantly, Black and Hispanic patients are more likely to experience delayed diagnosis and incomplete follow-up after echocardiographic identification of severe aortic stenosis (Carroll, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement). As noted in our white paper on this topic, “even after echocardiographic diagnosis of severe aortic stenosis, Black patients had over four-fold declining AVR, being lost to follow-up, and not being referred to cardiology,” with access barriers and gaps playing a role (ABC, Continuing to Address Gaps in Care in Minority Patients with Valvular Heart Disease, 2023, pp. 19–20).

As such, the evidence supports our contention that expanding Medicare coverage to include asymptomatic patients is a means to mitigate treatment delays, support proactive and planned care, while reducing the likelihood that patients from medically underserved communities seek care only once their disease has progressed to an advanced or emergent state and permanent heart damage has occurred.

Coverage with Evidence Development (CED): Urgent Need for Removal

Under the current NCD, Medicare coverage of TAVR is conditioned on participation in registries and compliance with procedural volume requirements under CED. While CED played an important role during the early adoption of TAVR, the cumulative evidence generated over more than a decade now supports routine, standard-of-care use. Specifically, the data demonstrates that TAVR outcomes are excellent in both high and low volume facilities and that procedural volume is no longer a reliable surrogate for quality (de Biasi AR, Paul S, Nasar A, Girardi LN, Salemi A. National Analysis of Short-Term Outcomes and Volume-Outcome Relationships for Transcatheter Aortic Valve Replacement in the Era of Commercialization. Cardiology. 2016;133(1):58-68. doi:10.1159/000440694).

The continuation of CED has had unintended but predictable consequences for access to care. Although there are no biologic differences observed in African Americans with regard to valvular heart disease prevalence, Black Americans have experienced significant, consistent underutilization of minimally invasive transcatheter valve therapies to treat aortic, mitral and tricuspid valve disease. CED requirements restrict the number of eligible TAVR centers, limiting access for patients in rural and underserved areas. These policies limit geographic access, discourage the development of new programs, and constrain utilization despite clinical appropriateness (Alliance for Aging Research, Comments submitted to CMS Administrator Seema Verma on Proposed decision on Medicare’s National Coverage Decision (NCD) for transcatheter aortic valve replacement (TAVR) (CAG-00430R). April 2019. https://www.agingresearch.org/wp-content/uploads/2018/07/CMS-Proposed-TAVR-Decision-Response-4-25-19.pdf).

As such, we strongly urge CMS to make the removal of the CED requirements a central element of this reconsideration. Retiring the CED requirement and issuing an NCD consistent with FDA-approved indications supports the goal of patient-centered, value-based coverage which prioritizes outcomes over structural constraints that no longer reflect current evidence.

Access and Utilization Considerations

Despite representing nearly 20% of the Medicare-aged population, Black and Hispanic beneficiaries account for a relatively small proportion of TAVR recipients nationwide. Registry data summarized by the Association of Black Cardiologists indicate that Black patients represent approximately 4% of TAVR recipients, a figure that has remained largely unchanged over the past decade despite expanded indications and increasing procedural volumes (Carroll, et al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement). This sustained pattern suggests that limitations in access to care, rather than clinical appropriateness, continue to influence utilization.

Conclusion

For these reasons, we urge CMS to revise the TAVR National Coverage Determination to include asymptomatic patients with severe aortic stenosis and to remove the CED requirements. Doing so would reflect the current evidence, improve access to life-saving therapy, and reduce avoidable access barriers for Medicare beneficiaries.

Thank you for this opportunity to provide comment and for your continued leadership in advancing evidence-based and equitable Medicare coverage policy.

Less

January 14, 2026

RE: CAG-00430R2 National Coverage Analysis for Transcatheter Aortic Valve Replacement

The American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), the Heart Failure Society of America (HFSA), Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS) are the professional medical societies representing the physicians and health care professionals who care for aortic stenosis patients who undergo transcatheter (TAVR) or surgical (SAVR) aortic valve replacement procedures for the treatment of severe aortic stenosis (AS). We appreciate the opportunity to respond to the Centers for Medicare & Medicaid Services’ (CMS) request for comment on this National Coverage Analysis (NCA) to reconsider the national coverage determination (NCD) for TAVR. We strongly recommend continuation of the NCD under Coverage with Evidence Development (CED), grounded in the principles outlined in the 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement (Bavaria et al., 2019).

Background

The Societies joined together to provide recommendations for institutions and operators to assess their suitability for instituting and/or maintaining a high-quality TAVR program. The 2018 consensus document (Bavaria et al., 2019) served as a framework for the original NCD update and continues to provide the foundational principles for program standards. Building on that foundation, the Societies now recommend that CMS update the TAVR NCD to incorporate new indications approved by the U.S. Food and Drug Administration (FDA)—such as treatment for asymptomatic AS and to anticipate future expanded indications for TAVR, including aortic regurgitation, bicuspid aortic stenosis, moderate aortic stenosis, and others. As TAVR has become integral to the care of patients with AS, the impact of an updated NCD will be profound and far-reaching, influencing not only patients who undergo TAVR but also the broader systems of care for all individuals with aortic valve disease. Accordingly, the standards specified in the document set criteria for the initiation and maintenance of TAVR programs in the spirit of optimizing quality outcomes and safety for all patients with AS. These requirements include:

• Coordinated care by a multi-disciplinary heart team (MDHT) that incorporates a patient-centered shared decision-making process. The complexities of AS care require a comprehensive, team-based approach.
• Minimum performance on quality benchmarks. All sites should measure and report outcomes of AVR. Sites with worse than expected performance for two consecutive reporting periods should enter a remediation process and conduct a thorough programmatic assessment, identify gaps and opportunities for improvement, and implement corrective action plans. To enable valid comparison against national benchmarks, risk-adjusted data and analytics ideally can be utilized from both the STS-ACC Transcatheter Valve Therapy (TVT) Registry and the STS Adult Cardiac Surgery National Database.
• Program Proficiency Surrogates (Volume Thresholds or External Program Monitoring). Volume requirements are needed to maintain program effectiveness and garner sufficient sample size for quality measurement. Although important for all TAVR sites, it is especially critical that sites not meeting volume thresholds establish rigorous monitoring and active quality assessment and improvement processes. Such activities are often facilitated by external review.
• Active participation in a prospective, national, audited registry is essential. Only through continued data collection, analysis, and feedback can clinical questions and the performance of TAVR for new indications regarding procedural outcomes be answered under CED.

Furthermore, use of the audited TVT Registry—built on a single, standardized Case Report Form (CRF) with agreed upon definitions—is essential for monitoring quality and patient outcomes, as opposed to administrative or EHR-scraped data. This approach enables accurate monitoring of quality and patient outcomes. The ability to directly assess real-world outcomes is increasingly important for beneficiary access to emerging technologies.

The multi-society consensus document provides guidance and support for a large number of centers throughout the U.S., emphasizing quality outcomes. While the professional societies do not explicitly recommend that sites failing to meet all requirements end their TAVR programs, it is essential that all TAVR sites continue reporting data to a national registry. Ongoing data collection and analysis enable quality outcome measurements. Sites should review their quarterly outcome reports to assess performance against national benchmarks.

Coverage Indications
Since the first TAVR NCD, coverage has aligned with those indications approved by the U.S. FDA, enabling the policy to evolve as evidence develops. At present, the NCD still restricts coverage to symptomatic AS; therefore, the newly FDA-approved indication for asymptomatic AS is not covered outside of clinical trials. The Societies recommend CMS consider updating the coverage indication to “aortic valve disease” to enhance the longevity of the NCD should future studies garner additional indications from the FDA for TAVR procedures to address aortic regurgitation, moderate aortic stenosis, and other evolving potential indications.

Structural Requirements
The current standards and requirements have produced one of the most successful rollouts of a new therapeutic procedure in history. CMS has created a well-functioning, high-quality service model that supports the entire care team. The Societies strongly believe that continuation of the current model is essential to ensure maintenance of the highest quality and safe patient outcomes.

Available evidence supports the concept that certain skills, experience, procedural volumes, and facility capabilities are required of institutions and operators to demonstrate the appropriate infrastructure for a successful TAVR program. These standards are explained in Section 4 of the multi-society consensus document and summarily displayed in Tables 4 and 5 (Bavaria et al., 2019). Robust analyses from the TVT Registry have consistently demonstrated an inverse relationship between TAVR volume and clinical outcomes. Among 113,662 intermediate- and high-/prohibitive-risk patients treated at 555 U.S. hospitals (2015–2017), risk-adjusted 30-day mortality was inversely associated with both hospital and operator volumes (Vemulapalli et al., 2019). In a larger cohort of 384,394 patients undergoing TAVR at 453 hospitals (2013-2022), including low-risk patients, lower hospital volume was associated with higher 30-day mortality and morbidity (Kumbhani et al., 2024). Most recently, an operator-level analysis of 358,943 TAVR patients treated at 827 hospitals (2020-2023) demonstrated inverse associations between operator volume and procedural success, 30-day mortality, and morbidity (Kumbhani et al., 2026).

Together, these findings support a blended quality framework that incorporates both outcomes-based metrics and minimum volume thresholds, rather than reliance on outcomes alone. The Societies recommend revisiting the volume requirements to ensure they reflect current evidence. Any changes to volume thresholds should be contingent on mandatory reporting to a national, audited registry to enable ongoing monitoring.

Minimum volume requirements are particularly important given the well-defined learning curve for new operators and programs, which are often low-volume. In addition, low event rates for outcomes such as mortality and stroke limit the reliability of quality assessments at low-volume sites due to wide confidence intervals and greater statistical uncertainty. Recent data also demonstrate inferior process-of-care metrics among low-volume operators (for instance, longer procedure times, greater contrast use, and higher post-procedure gradients and paravalvular regurgitation)—factors likely to influence long-term outcomes, and a particularly important consideration for low-risk patients (Kumbhani et al., 2026). While some sites and operators below volume thresholds may still deliver high-quality TAVR care, rigorous program oversight (including continuous quality assessment, root cause analysis, and targeted improvement efforts) is especially critical in these settings. These volume and institutional requirements will become even more important as the indications for TAVR expand.

Available evidence supports defining minimum thresholds for hospitals and operators below which outcomes are statistically and meaningfully different. Based on available data from the TVT registry, this threshold could be defined as <37 procedures per year for hospitals (Vemulapalli et al., 2019) and <15 per year for operators (Kumbhani eta al., 2026), which is concordant with <16 per year for operators reported in 2019 (Vemulapalli et al., 2019). While there is no clear evidence-based answer for the minimum volume below which statistical uncertainty about quality becomes significant, CMS previously listed 20 per year for hospitals in the 2019 NCD to address this issue. We strongly support continuing these minimum volume requirements.

Finally, the societies recommend eliminating the PCI volume requirement, as recent evidence indicates PCI volume is not associated with TAVR outcomes (Butala et al., 2020). The original rationale for PCI volume was to ensure adequate cath lab infrastructure, which can now be assessed through other structural and process measures.

Process Requirements
Best practices and standardized processes for a quality TAVR program are addressed in Section 5 of the multi-society consensus document. These include the incorporation of appropriate use criteria for patient selection, coordination of care and decision-making by a multi-disciplinary team, and inclusion of valvular heart disease patients and their families in a shared decision-making process. The integral role of the multi-disciplinary heart team in joint decision making and procedures is essential to guide optimal therapy for patients with aortic valve disease, and we strongly support continuing these requirements.

Outcome Requirements
In Section 6, multi-society consensus document (Bavaria et al., 2019) identifies relevant outcome measures and sets requirements for programs to demonstrate quality. These include outcome measures for both isolated SAVR and TAVR. TAVR centers must take immediate action and consider outside reviews to address signals of poor performance. Importantly, more recent literature shows that a modeled outcome-based spoke and hub paradigm of TAVR care has the potential to improve national outcomes to a greater extent than a simulated volume threshold. While no significant reduction in estimated adverse events was noted between TAVR sites performing 50 or more versus less than 50 TAVR procedures annually, transitioning care to the best outcome site in a hospital referral area resulted in significantly fewer adverse events (Nelson et al., 2023).

Registry Requirements
For both the recently approved indication for asymptomatic AS and any future indications, it is critical to demonstrate that real-world outcomes match the safety and effectiveness reported from clinical trials. The EARLY TAVR trial (Généreux et al., 2025) randomized 901 patients with asymptomatic severe AS at 75 centers to either TAVR with a balloon-expandable valve (n=455) or clinical surveillance (n=466). TAVR was superior to clinical surveillance in reducing the composite primary end point of death, stroke, or unplanned hospitalization for cardiovascular causes. These results supported FDA approval of TAVR for asymptomatic severe AS in this patient cohort. However, it remains essential to demonstrate that similar outcomes can be achieved in routine, real-world practice. This is necessary to not only confirm safety and effectiveness but also to ensure the procedure meets Medicare’s standard of being reasonable and necessary for beneficiaries. Because randomized controlled trials occur in controlled environments in a highly-selected patient population, real-world evidence-such as data from the TVT Registry—is essential to validate that TAVR for asymptomatic AS delivers comparable results in broader patient populations.

The Societies strongly believe that continuation of the CED paradigm is essential to address existing and emerging clinical questions. Submission of data on all TAVR procedures to a national registry should remain a requirement. Section 7 in the multi-society consensus document (Bavaria et al., 2019) details how data should be collected and used to assess the ongoing evolution and dissemination of TAVR technology. Data collection by a national registry facilitates programmatic assessment and quality improvement, and the current requirement has already facilitated expanded access for Medicare beneficiaries—supporting FDA label expansions for TAVR to treat bioprosthetic structural valve deterioration and alternative vascular access approaches. Moreover, registry data have advanced the field’s understanding of valve disease therapies with close to 150 papers published in several high-impact journals as of this writing, including NEJM, Lancet, JAMA, Health Affairs, Journal of the American Medical Association Cardiology, Circulation, and the Journal of the American College of Cardiology, among others. More importantly, registry data will remain essential for addressing major clinical questions – such as optimal patient selection, long-term device durability, especially with yet to be approved devices from additional manufacturers, and real-world outcomes in asymptomatic patients. Lifetime management of asymptomatic patients, in particular, is going to be very important, as long-term data are still limited in this patient population.

As indications expand and technology evolves, these questions cannot be answered without comprehensive, real-world evidence. For this reason, we strongly urge CMS to maintain the CED framework to ensure ongoing data collection and analysis. Future CED should focus on specific questions, including:

1. What are long-term outcomes, including mortality and associated patient factors in low-risk and asymptomatic AS patients?
2. What are health status outcomes and quality of life outcomes at one year, especially among asymptomatic patients?
3. Which institutional and operator characteristics are associated with better short-and long-term outcomes?
4. How do real-world outcomes for asymptomatic patients compare with pivotal trials used for FDA approval?
5. What are the utilization patterns and clinical impacts of emerging adjunctive therapies and technologies such as aortic regurgitation and treatment of moderate aortic stenosis which have been fully enrolled in clinical trials?
6. What patient-level risk factors for TAVR versus SAVR can better inform shared decision-making to define profiles for optimal procedural selection?
7. How should the barriers to access for all cardiac services that exist for underserved populations be overcome and how would this best be implemented?
8. Do patients diagnosed with asymptomatic aortic stenosis, based on current guideline criteria, experience outcomes that confirm TAVR is reasonable and necessary compared to clinical trials?

These questions become even more relevant if infrastructure, facility, and operator standards are reduced in the future. It will be imperative to track utilization and outcomes of TAVR for new indications as it disperses to smaller facilities that would provide services at lower volumes. Additionally, future CED should ensure consistent application of guideline-based definitions for asymptomatic status and standardized echocardiographic criteria for severe AS, as these are critical for accurate data collection and interpretation.

Once the TAVR field reaches maturity and sufficient real-world evidence has been collected, sunsetting CED requirement could be considered. However, given several important indications on the horizon—including valve-in-valve procedures, treatment of aortic regurgitation, and moderate AS—continued evidence development remains critical in the near term.

Access to TAVR Therapy
It is encouraging that since the last NCD reconsideration in 2019, there has been an increase in TAVR sites. Many of these are in underserved regions. It is important that they remain active if they can document acceptable quality, even if they fall below volume thresholds. A recent analysis from the TVT Registry demonstrated that between 2017 and 2023, the number of U.S. hospitals performing TAVR increased by 49%, while the number of operators increased 1.5-fold (150%). Despite this expansion, 21% of TAVR operators in the United States currently perform =10 TAVRs annually—averaging less than one case per month. Further expansion could lead to additional volume dilution and redistribution (Kumbhani et al., 2026). Researchers have also found that 92.1% of those over 65 years live in a hospital referral region containing a TAVR center, and patients receiving TAVR drive a median time of 35 minutes (Marquis-Gravel et al., 2020). This study was conducted between 2015 and 2017, (prior to the last NCD consideration), and is likely even shorter today, given the increase in TAVR sites from 550 in 2017 to 860 in 2025.

We acknowledge that geographic challenges and other barriers accessing TAVR exist (David et al., 2025). The U.S. has many regions of low population density. Consequently, access to high-quality TAVR may require additional travel time and expense for patients who live farther away from a TAVR program. Striking the right balance between maintenance of high-quality outcomes and providing adequate access to care geographically needs to be continually assessed with evidence.

Barriers to medical care in the U.S. are complex and multifactorial and access to TAVR is no different in more densely populated areas. Socioeconomic, cultural, even transportation obstacles can hinder patient access to health care anywhere in the country (Nathan et al., 2021). To that end, education of providers on the identification and treatment of aortic stenosis must increase significantly, in a focused and structured manner, so that candidates for TAVR therapy are correctly identified and referred for specialized care. However, we do not believe that many additional TAVR sites would or should open as they are unlikely to meet adequate volume standards.

Currently, there are 860 TAVR sites reporting data to the TVT Registry, compared with 550 sites nationally during 2015-2017 when it was estimated that 10% of patients lived far from a TAVR center (Marquis-Gavel et al., 2020). Therefore, the proportion of patients without nearby access is likely smaller. Furthermore, more than half of new TAVR sites opening after 2015 were located within a 30-minute drive of an existing center (Valle et al., 2021), suggesting that lowering program standards and expanding site numbers alone is unlikely to meaningfully improve access. There are roughly 1050 cardiac surgery programs in the country. Most of the roughly 200 surgical sites that are not currently performing TAVR are either geographically close to already existing TAVR sites or lack key structural elements necessary for an optimal program. Removing facility and volume standards could compromise patient outcomes without significantly addressing access gaps.

The Societies thank CMS for the opportunity to comment on the NCA for the reconsideration of the TAVR NCD and would be pleased to engage with CMS further on this issue. Please direct any questions or concerns to Amanda Stirling, Regulatory Affairs Associate, at 202-375-6553 or astirling@acc.org.

Sincerely,

Emile A. Bacha, MD
President, American Association for Thoracic Surgery

Christopher M. Kramer, MD, FACC
President, American College of Cardiology

Kenneth B. Margulies, MD
President, Heart Failure Society of America

Srihari S. Naidu, MD, MSCAI
President, Society for Cardiovascular Angiography and Interventions

Joseph F. Sabik III, MD
President, The Society of Thoracic Surgeons

References
1. Bavaria, J, Tommaso, C, Brindis, R. et al. 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement: A Joint Report of the American Association for Thoracic Surgery, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. JACC. 2019 Jan, 73 (3) 340–374.
2. Vemulapalli S, Carroll JD, Mack MJ, et al. Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. N Engl J Med. Jun 27 2019;380(26):2541-2550.
3. Kumbhani DJ, Manandhar P, Bavry AA, et al. National Variation in Hospital MTEER Outcomes and Correlation With TAVR Outcomes: STS/ACC TVT Registry Analysis. JACC Cardiovasc Interv. Feb 26 2024;17(4):505-515.
4. Kumbhani DJ, Girotra S, Dong H, et al. Contemporary Operator Procedural Volumes and Outcomes for TAVR and MTEER in the US. JAMA Cardiol. Published online January 08, 2026.
5. Butala NM, Bucholz EM, Kolte D, Elmariah S. Association of Hospital Inpatient Percutaneous Coronary Intervention Volume With Clinical Outcomes After Transcatheter Aortic Valve Replacement and Transcatheter Mitral Valve Repair. JAMA Cardiol. 2020 Apr 1;5(4):464-468.
6. Nelson AJ, Wegermann ZK, Gallup D, et al. Modeling the Association of Volume vs Composite Outcome Thresholds With Outcomes and Access to Transcatheter Aortic Valve Implantation in the US. JAMA Cardiol. 2023;8(5):492–502.
7. Généreux P, Schwartz A, Leon MB, et al. Early TAVR for asymptomatic severe aortic stenosis in low-risk patients: the EARLY TAVR trial. N Engl J Med. 2025;392(3):217–227.
8. Marquis-Gravel G, Stebbins A, Kosinski AS, et al. Geographic access to transcatheter aortic valve replacement centers in the United States: Insights from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. JAMA Cardiol. 2020;5(9):1006-1010.
9. David G, Epstein AJ, Giri J, et al. No-transcatheter aortic valve replacement (TAVR) zones and their effect on access to care for Medicare beneficiaries with aortic stenosis. Adv Ther. 2025;42:1716-1728.
10. Nathan AS, Yang L, Yang N, et
al. Racial, ethnic, and socioeconomic disparities in access to transcatheter aortic valve replacement within major metropolitan areas. JAMA Cardiol. 2022;7(2):150-157. 11. Valle JA, Li Z, Kosinski AS, Nelson AJ, Vemulapalli S, Cleveland J, Fullerton D, Messenger JC, Rove JY, Bricker RS, Bradley SM, Masoudi FA, Yeh RW, Armstrong EJ, Waldo SW, Carroll JD. Dissemination of Transcatheter Aortic Valve Replacement in the United States. J Am Coll Cardiol. 2021 Aug 24;78(8):794-806. doi: 10.1016/j.jacc.2021.06.028. PMID: 34412813.
12. Hirji S, Trager L, Harloff M, Yazdchi F, Percy E, McGurk S, Malarczyk A, Aranki S, Shekar P, Kaneko T. Surgical Aortic Valve Replacement Outcomes in Non-Transcatheter Aortic Valve Replacement Centers: Implications for Tier-Based Systems of Care. Ann Thorac Surg. 2022 Jan;113(1):66-74.
13. Hirji SA, McCarthy E, Kim D, McGurk S, Ejiofor J, Ramirez-Del Val F, Kolkailah AA, Rosner B, Shook D, Nyman C, Berry N, Sobieszczyk P, Pelletier M, Shah P, O'Gara P, Kaneko T. Relationship Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes. JACC Cardiovasc Interv. 2020 Feb 10;13(3):335-343.
14. Kundi H, Popma JJ, Khabbaz KR, Chu LM, Strom JB, Valsdottir LR, Shen C, Yeh RW. Association of Hospital Surgical Aortic Valve Replacement Quality With 30-Day and 1-Year Mortality After Transcatheter Aortic Valve Replacement. JAMA Cardiol. 2019 Jan 1;4(1):16-22.
15. Elbadawi A, Mohamed A, Sedhom R, Garcia L, Pandey A, Girotra S, Bavry A, Vemulapalli S, Kumbhani DJ. Clinical Outcomes in Relation to Total Hospital Surgical and Transcatheter Aortic Valve Replacement Volumes. J Am Heart Assoc. 2024 Oct;13(19):e035719.

Less

JoAnna Baldwin
Deputy Director, Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Re: CAG-00430R2 National Coverage Analysis: Transcatheter Aortic Valve Replacement (TAVR) (and Broader CED Policy Considerations)

Dear Ms. Baldwin,

As authors of “A Roadmap for Improving Medicare’s Application of Coverage With Evidence Development” recently published in Value in Health,[1] we are writing to comment on the request to reconsider the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) 20.32 and, more broadly, on the application of Coverage with Evidence Development (CED) policy. [*NOTE: The opinions expressed herein represent those of the authors and do not represent the positions of any of their affiliated organizations] The request to reconsider the TAVR NCD presents an important opportunity for CMS to demonstrate how CED requirements should be appropriately retired when evidentiary goals have been met, consistent with several key recommendations we have made for improving CED policy.

Clear Criteria for Applying CED and Ending CED Requirements

As has been documented in the academic and gray literature, the lack of clarity around the criteria and process for applying and reconsidering CED requirements has been a significant concern.[2] In our 2023 comments on CMS’s proposed CED guidance, we recommended that CMS “adopt clear and predictable criteria for when CED should be considered, enabling patient groups, physicians, hospitals, and innovators to know when to expect the implementation of CED and plan accordingly.”[3] The same principle applies to criteria for ending CED: stakeholders should be able to anticipate when CED requirements will be retired based on objective, pre-specified standards.[1] TAVR represents one of the longest-standing CED requirements, with coverage first established in 2012 and updated in 2019. The extensive body of evidence now available—including over 30 clinical trials and robust registry data from the STS/ACC TVT Registry—appears to address the original CED questions posed by CMS. Notably, in 2019, CMS indicated that developing a periprocedural composite metric incorporating relevant patient health outcomes was a priority, stating that procedure-related factors contributing to TAVR outcomes “must be addressed through a composite metric.”[4] That composite measure, along with the underlying data to drive it, was published in 2021, drawing on a development cohort of over 52,000 patients and subsequently implemented for public reporting.[5] Had a transparent framework for evaluating when CED questions are satisfied existed at that time, CMS could have initiated reconsideration of the TAVR CED requirements approximately four years ago.

We recommend that CMS use this reconsideration as an opportunity to articulate clearly how CED requirements will be evaluated for retirement across all cases. This process should include:

1. Objective, ex ante criteria for success: Before CED studies are implemented, CMS should work with stakeholders to develop objective criteria—based on outcomes that matter most to patients—that would trigger various CED outcomes (extension, removal, or revocation of the NCD).[3]


2. Time-limited CED with defined review milestones: As we have previously recommended, “CED would apply for up to 3 years, or when the research questions are answered through sufficient data collection and objective analysis, whichever comes first,” with “an option to extend CED longer than 3 years, not to exceed another 2 years, if significant new evidence arises.” We have stated that “CED should not last more than five years under any circumstances.”[3] CED requirements lasting more than a decade, as with TAVR, risk undermining the policy’s credibility and effectiveness.


3. Fit-for-purpose data collection: We have consistently recommended that CED requirements be “narrowly address[ed] to the questions or concerns identified, and remov[ed] as soon as those questions are answered.”[3] Data collection activities should be limited to information necessary to answer the original research questions posed by CED, avoiding unnecessary burdens on clinicians and patients. When validated quality measures become available that directly address CED questions—as occurred with TAVR in 2021, when both the composite measure and the underlying registry data to support it were published and subsequently implemented for public reporting—CMS should evaluate whether continued CED requirements remain necessary or whether they impose burdens that exceed their informational value.

Distinguishing CED’s Purpose from Ongoing Quality Improvement

CED is designed to answer specific evidentiary questions about a technology's safety and effectiveness—not to serve as a permanent infrastructure for quality improvement. While the TVT Registry has yielded valuable quality improvement benefits, these are ancillary to CED's core purpose: as we noted in our 2023 comments, CED requirements should be "narrowly address[ed] to the questions or concerns identified, and remov[ed] as soon as those questions are answered."[3] Unless Congress otherwise grants CMS the authority, it is the responsibility of professional societies, academic institutions, healthcare systems, industry and other non-governmental stakeholders in the healthcare ecosystem—not CMS—to sustain ongoing quality improvement efforts. Conflating CED's evidentiary function with quality improvement risks perpetuating requirements beyond their intended purpose and creates misaligned incentives for stakeholders who benefit financially from continued mandatory registry participation.

Prioritizing Patient Preferences and Access

Incorporating patient-centered outcomes and validated patient preference information is crucial in both applying and evaluating CED requirements. In our 2023 comments, we recommended that CMS adopt “a patient-centered approach to decision-making that includes the patient voice and perspective” and that the level of significance of outstanding questions “should be weighed using the priority outcomes of the targeted patient population, supported with evidence of the patient community’s perspective.”[3] Published research on patient preferences for TAVR treatment attributes demonstrates how such data could inform CED policy decisions. A 2021 study found that patients would tolerate a maximum acceptable mortality risk of 12.6% following TAVR—substantially higher than the actual 1.1% mortality rate observed with TAVR—and a maximum acceptable stroke risk of 20.7%, far exceeding observed stroke rates.[6] Had CMS incorporated validated patient preference data into its evaluation of TAVR CED requirements, the agency may have concluded earlier that the risk-benefit profile of TAVR fell well within patients’ tolerance levels for the specific outcomes of concern, potentially accelerating the timeline for reconsidering CED requirements.

We also urge CMS to consider how outdated NCD requirements may create barriers to timely patient access, particularly for underserved populations. In our 2023 comments, we noted that “coverage constraints that are fit for the purpose of data collection” should guide CED implementation, and that “if a goal of CED is to collect real-world evidence, coverage should not be limited to ‘centers of excellence.’”[3] Recent analysis of CMS data confirms that TAVR’s center-of-excellence requirements have exacerbated geographic and socioeconomic disparities in access.7 CED-qualified hospitals are distributed unequally across the country, precluding access for patients in access-challenged regions: 14-16% the patients treated at CED-qualified hospitals (i.e. those participating in CED registries and clinical trials) reside in rural areas, compared with 21-25% of the patients treated at non-CED qualified hospitals. Similarly, CED-qualified hospitals treat fewer low-income subsidy (LIS)-enrolled patients and fewer patients residing in socioeconomically disadvantaged neighborhoods. These constraints not only reduce equitable access but also undermine a key goal of CED: to generate evidence on a nationally representative sample of clinically eligible Medicare beneficiaries. Instead, restricted coverage skews the use of technologies like TAVR to patients with ready access to academic medical centers and other high-end medical facilities. Moreover, additional research has shown that CED requirements have distorted markets and skewed TAVR adoption toward physician practices facing less competition, as the requirements for substantial prior procedural volume and high upfront investments have favored practices earning higher profits on larger market shares.[7]

Conclusion

The request to reconsider the TAVR NCD provides CMS with an important opportunity to demonstrate effective implementation of CED policy principles, particularly as they relate to CMS’s commitment to ending CED. As CMS’s Guidance states, “CMS does not believe that an NCD that requires CED as a condition of coverage should last indefinitely.”[8] We recommend that CMS:

1. Establish a transparent framework with objective, pre-specified criteria for evaluating when CED requirements have been satisfied and should be retired.


2. Enforce time limits on CED, ensuring that requirements do not extend beyond five years without compelling justification.


3. Incorporate validated patient preference data into decisions about both the application and termination of CED requirements.


4. Consider patient access implications of NCD requirements, particularly their impact on underserved populations.

These principles should apply not only to TAVR but to all technologies currently covered under CED requirements. We encourage CMS to use this reconsideration as a model for implementing an improved, predictable approach to CED that balances evidence generation with timely patient access. CMS should also develop a framework clarifying when CED is appropriate, particularly considering that it may better suit medical devices than pharmaceuticals given differences in FDA approval standards, care settings, and the greater dependence of device outcomes on provider skill and intervention. As policy researchers, we appreciate the opportunity to comment on this important NCD reconsideration and the broader implications for CED policy. We would be happy to provide any additional information or clarification that might be helpful in improving the CED process across all applications.

Respectfully,

Darius Lakdawalla, PhD
Quintiles Chair in Pharmaceutical Development and Regulatory Innovation
University of Southern California Schaeffer Center for Health Policy & Economics

Sean Tunis, MD
Senior Fellow
Tufts Center for Evaluation of Value and Risk in Health

Peter Neumann, ScD
Director, Center for the Evaluation of Value and Risk in Health
Institute for Clinical Research and Health Policy Studies, Tufts Medical Center

Danielle Whicher, PhD
Senior Researcher
Mathematica

Emily Zeitler, MD MHS
Associate Professor of Medicine
The Dartmouth Institute for Health Policy and Clinical Practice
Geisel School of Medicine at Dartmouth

Barry Liden, JD
Director of Public Policy
USC Schaeffer Center for Health Policy & Economics

References
1. Lakdawalla D, Tunis S, Neumann P, Whicher D, Zeitler E, Liden B. A Roadmap for Improving Medicare’s Application of Coverage With Evidence Development. Value Health. 2024;0(0). doi:10.1016/j.jval.2024.05.008
2. Zeitler EP, Gilstrap LG, Coylewright M, Slotwiner DJ, Colla CH, Al-Khatib SM. Coverage with evidence development: where are we now? Am J Manag Care. 2022;28(8):382-389. doi:10.37765/ajmc.2022.88870
3. Comments to CMS on Proposed Guidance for Coverage with Evidence Development. USC Schaeffer. August 25, 2023. Accessed January 12, 2024. https://healthpolicy.usc.edu/article/comments-to-cms-on-proposed-guidance-for-coverage-with-evidence-development-ced/
4. NCA - Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R) - Decision Memo. Accessed January 13, 2026. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=293&bc=ACAAAAAAQAAA&
5. Desai ND, O’Brien SM, Cohen DJ, et al. Composite Metric for Benchmarking Site Performance in Transcatheter Aortic Valve Replacement: Results From the STS/ACC TVT Registry. Circulation. 2021;144(3):186-194. doi:10.1161/CIRCULATIONAHA.120.051456
6. Marsh K, Hawken N, Brookes E, Kuehn C, Liden B. Patient-centered benefit-risk analysis of transcatheter aortic valve replacement. F1000Research. 2021;8:394. doi:10.12688/f1000research.18796.5
7. Lakdawalla D. Testimony on Accelerating Medical Breakthroughs for American Patients and Their Families - December 9, 2025. USC Schaeffer. December 9, 2025. Accessed January 13, 2026. https://schaeffer.usc.edu/research/testimony-accelerating-medical-breakthroughs-for-patients/
8. Medicare Coverage Document - Coverage with Evidence Development. Accessed January 13, 2026. https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=38

Less

January 14, 2026

Administrator Mehmet Oz
Centers for Medicare & Medicaid Services
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Oz,

As members of the Heart Valve Disease Policy Task Force, a national group of 30 leaders including clinician and patient advocates, we appreciate the opportunity to comment on the National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR). We urge CMS to modernize the TAVR NCD to reflect the robust and mature evidence base, evolving clinical practice, and the critical need to ensure timely, equitable access for Medicare beneficiaries with aortic stenosis (AS), a life-threatening condition.

The current TAVR NCD must be updated to allow timely patient access to new and evolving FDA-approved indications, including the treatment of select patients with asymptomatic AS. Emerging clinical evidence and ongoing trials increasingly demonstrate that earlier intervention in appropriately selected asymptomatic patients may prevent irreversible cardiac damage, reduce downstream morbidity, and improve long-term outcomes [1].

Coverage policy that relies solely on symptom status risks delaying care until disease progression results in poorer outcomes and increased healthcare utilization. Medicare beneficiaries should not be required to wait for clinical deterioration when earlier, evidence-based intervention may preserve quality of life and improve survival. Aligning coverage with contemporary evidence would ensure patients can access advances in early diagnosis and treatment without unnecessary delay.

In addition to expanding indications, we also encourage CMS to remove outdated and burdensome NCD requirements that create unnecessary barriers to patient care. TAVR is now established as the standard of care for patients with AS, yet certain structural and procedural requirements no longer reflect current practice patterns or patient needs. These outdated mandates, including rigid specifications on the number of operators during the procedure, may delay or prevent timely access to treatment for a condition that is both progressive and life-threatening. We believe the determination of how many qualified physicians are required for each TAVR procedure should be left to the discretion of the hospital based on clinical judgment, team experience, and patient needs. Streamlining these requirements would support more efficient care delivery while maintaining high standards for quality and patient safety.

The evidence also clearly demonstrates that TAVR is reasonable and necessary for the treatment of AS and no longer requires Coverage with Evidence Development (CED) [2]. The continued application of CED requirements is inconsistent with the maturity of the evidence base and the widespread integration of TAVR into standard clinical practice. These administrative burdens restrict access to patient care, contribute to the closure of existing TAVR Centers, discourage the establishment of new centers, and exacerbate disparities in treatment outcomes. Research shows that patient proximity to hospitals significantly influences where care is received, even when reported health outcomes differ across facilities [3]. Sunsetting CED would better align Medicare policy with current science and clinical experience while reducing unnecessary barriers for both providers and patients.

Health equity and geographic access must remain central considerations in any updates to the TAVR NCD. Hospital and operator volume requirements, while originally intended to protect patient outcomes, can pose significant barriers for hospitals serving under-resourced, rural, or socioeconomically disadvantaged communities. These policies may inadvertently contribute to inequitable geographic distribution of TAVR services, leading to longer travel distances, increased wait times, and lower utilization rates among vulnerable populations [4].

Evidence shows that access to TAVR becomes more equitable as the number of hospitals offering the procedure increases. From 2016 to 2019, a 30 percent increase in the number of TAVR hospitals coincided with a 31 percent decrease in procedure access inequality [5]. Given that AS remains significantly undertreated, we believe access to care can be improved in part by appropriately expanding the number of centers able to offer TAVR.

Like many therapies in healthcare, the availability of TAVR should be guided by community and patient need rather than arbitrary hospital or operator volume thresholds. At a minimum, programs already providing structural heart care should have the flexibility to offer TAVR where clinically appropriate. Over time this may reasonably include the addition of several hundred centers over time as patient demand and community need warrant, ensuring that Medicare beneficiaries can receive timely care close to home.

In conclusion, we strongly encourage CMS to modernize the TAVR NCD by expanding indications, sunsetting CED requirements, and removing outdated barriers that unnecessarily limit patient access. An updated, evidence-based coverage policy will better reflect current clinical practice, improve health equity, and ensure that Medicare beneficiaries with aortic stenosis can access timely, life-saving care regardless of geography or socioeconomic status.

We appreciate the opportunity to provide these comments and look forward to continued collaboration with CMS to advance patient-centered, equitable coverage policies.

Thank you for your consideration of this important issue.

Sincerely,
The Heart Valve Disease Policy Task Force

Alliance for Aging Research
Alliance for Patient Access
Caregiver Action Network
Heart Valve Voice US
Hypertrophic Cardiomyopathy Association
Men's Health Network
The Mended Hearts, Inc.
National Minority Quality Forum
Partnership to Advance Cardiovascular Health
Preventive Cardiovascular Nurses Association
WomenHeart: The National Coalition for Women with Heart Disease

[1] Philippe Généreux, Schwartz, A., J. Bradley Oldemeyer, Philippe Pibarot, Cohen, D. J., Blanke, P., Lindman, B. R., Vasilis Babaliaros, Fearon, W. F., Daniels, D. V., Chhatriwalla, A. K., Kavinsky, C., Gada, H., Shah, P., Szerlip, M., Dahle, T., Goel, K., O’Neill, W., Sheth, T., & Davidson, C. J. (2024). Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2405880

[2] Carroll, J. D., Mack, M. J., Vemulapalli, S., Herrmann, H. C., Gleason, T. G., Hanzel, G., … Bavaria, J. E. (2020). STS-ACC TVT Registry of transcatheter aortic valve replacement. Journal of the American College of Cardiology, 76(21), 2492–2516. https://doi.org/10.1016/j.jacc.2020.09.595

[3] Alliance for Aging Research. Comments submitted to CMS Administrator Seema Verma on Proposed decision on Medicare’s National Coverage Decision (NCD) for transcatheter aortic valve replacement (TAVR) (CAG-00430R). April 2019. https://www.agingresearch.org/wp-content/uploads/2018/07/CMS-Proposed-TAVR-Decision-Response-4-25-19.pdf

[4] Damluji, A. A., Fabbro, M., Epstein, R. A., Rayer, S., Wang, Y., Moscucci, M., Cohen, M. G., Carroll, J. M., Messenger, J. C., Resar, J. R., Cohen, D., Sherwood, M. W., O’Connor, C. M., & Batchelor, W. (2020). Transcatheter Aortic Valve Replacement in Low-Population Density Areas. 13(8). https://doi.org/10.1161/circoutcomes.119.006245

[5] Bergman, A., David, G., Nathan, A., Giri, J., Ryan, M., Chikermane, S., Thompson, C., Clancy, S., & Gunnarsson, C. (2024). Measuring hospital inpatient Procedure Access Inequality in the United States. Health Affairs Scholar, 2(11). https://doi.org/10.1093/haschl/qxae142

Less

Dear Members of the Coverage and Analysis Group,

We appreciate the opportunity to comment on the reconsideration of the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).

At Stanford Biodesign, we believe that a disciplined approach to innovation across the continuum of care is the key to solving healthcare challenges in the U.S. and across the globe. For more than two decades, we’ve demonstrated that innovation can be taught, learned, practiced, and perfected. The Biodesign innovation process has been adopted by more than 100 universities and training programs around the world. Our trainees learn to observe patient needs and care delivery to identify the right opportunities for transformative impact. Over 18 million people have been helped by technologies invented during Stanford Biodesign training. From our position at the metaphorical and physical start line for healthcare innovation, we have observed the often decade-long journey for a novel health technology to become the standard of care treatment for a disease state. At the Stanford Biodesign Policy Program, we have focused our research on qualitative and quantitative evidence that elucidates this process from FDA authorization through clinical evidence generation to commercial viability, with an emphasis on how federal policy balances speed and risk.

The Centers for Medicare & Medicaid Services (CMS) established the Coverage with Evidence Development (CED) program in 2005 as a regulatory pathway to grant conditional national coverage for promising medical technologies while mandating the collection of clinical data on their use in the Medicare population [1]. This framework links reimbursement to participation in a CMS-approved clinical study or registry, thereby addressing evidentiary gaps that often persist after initial Food and Drug Administration (FDA) approval.

Transcatheter Aortic Valve Replacement (TAVR) became a prominent therapy governed by CED following its initial National Coverage Determination (NCD) in 2012 [2]. Clinical data collection on TAVR is primarily fulfilled through the Transcatheter Valve Therapy (TVT) Registry, which was designed to resolve key uncertainties regarding the technology’s real-world generalizability, long-term device durability, longitudinal patient outcomes, and performance across various patient subpopulations and risk profiles [3]. Today, the CED mandate for TAVR has successfully achieved its scientific objectives. Data from over 300,000 procedures now confirm that real-world outcomes meet or exceed those from pivotal clinical trials [4, 5]. The procedure’s safety profile is comparable to percutaneous coronary intervention (PCI), with 30-day mortality below 1% in low-risk patients [6]. Ten-year data demonstrate excellent device durability, with a reintervention rate of only 1.63% [7]. A validated 30-day composite quality metric now exists, enabling direct, risk-adjusted monitoring of site-level performance [8]. The original evidentiary questions have been answered.

However, the primary challenge of CED remains the lack of a defined timeframe for data collection. For TAVR, this absence has led to perpetual data collection and site-volume requirements that are no longer scientifically justified. Originally intended as safeguards, these mandates now function as significant barriers to access. They produce geographic care disparities and impose substantial travel burdens on rural and low-income populations [9].

To enhance the utility of the CED program, the Coverage and Analysis Group (CAG) should reframe its approach to CED determinations around the principle of evidence sufficiency. This principle distinguishes between the specific evidence sufficient to demonstrate that a therapy has met the threshold for "reasonable and necessary" and the broader, often unlimited, evidence that may be feasible with registry data or desired by academic, clinical, or payer stakeholders. CMS can support this principle by publishing disease-specific clinical endpoint guidance documents [10] and engaging with stakeholders prior to initiating a National Coverage Analysis (NCA). This approach ensures that CED serves as an instrument to resolve specific clinical evidence questions and does not become a mechanism for indefinite data collection.

For TAVR, the current clinical evidence is sufficient for CMS to determine the conditions under which the therapy is reasonable and necessary, for both symptomatic and asymptomatic patient populations. Continuing a mandatory registry for all AS patients serves no remaining scientific purpose and causes demonstrable harm.

Thank you for your consideration of these public comments.

References:
[1] Tunis SR and Pearson SD “Coverage Options For Promising Technologies: Medicare’s ‘Coverage With Evidence Development” Health Affairs 25, no. 5 (2006): https://doi.org/10.1377/hlthaff.25.5.1218
[2] Transcatheter Aortic Valve Replacement, 2012 to 2019: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=355&ncdver=1&
[3] The Society of Thoracic Surgeons / American College of Cardiology Transcatheter Valve Treatment (STS/ACC TVT) Registry. https://www.ncdr.com/WebNCDR/tvt/publicpage
[4] Smith, C.R., et al., Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med, 2011. 364(23): p. 2187-98. https://www.nejm.org/doi/full/10.1056/NEJMoa1103510
[5] Leon MB, et al., Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at Seven Years. N Engl J Med, 2025. DOI: 10.1056/NEJMoa2509766 N Engl J Med, 2019. 380(18): p. 1695-1705.
[6] Vekstein et al, “Outcomes of Transcatheter Aortic Valve Replacement in Low-Risk Patients in the United States: A Report From the STS/ACC TVT Registry” Circulation 2025 April 3; 151(16): 1134-1146. https://pubmed.ncbi.nlm.nih.gov/40177743/
[7] Thyregod et al. “Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial.” Eur Heart J 2024 Apr 1;45(13):1116-1124 https://pubmed.ncbi.nlm.nih.gov/38321820/
[8] Desai, N.D., et al., Composite Metric for Benchmarking Site Performance in Transcatheter Aortic Valve Replacement: Results From the STS/ACC TVT Registry. Circulation, 2021. 144(3): p. 186-194. https://pubmed.ncbi.nlm.nih.gov/33947202/
[9] Nathan, A.S., et al. Socioeconomic and Geographic Characteristics of Hospitals Establishing Transcatheter Aortic Valve Replacement Programs, 2012-2018. Circulation: Cardiovascular Quality and Outcomes. 2021 Nov. 14; 14(11). https://www.ahajournals.org/doi/10.1161/CIRCOUTCOMES.121.008260
[10] CMS Clinical Endpoint Guidance Knee Osteoarthritis. https://www.cms.gov/files/document/osteoarthritisoutcomes2024pdf.pdf

Less

Dear CMS Decision Makers,

As a structural heart specialist with over a decade of experience performing TAVRs and one having expertise in health policy and healthcare economics, I strongly support the proposed expansion of the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) to include coverage for asymptomatic patients with severe aortic stenosis (AS). This expansion is backed by robust clinical evidence and holds significant potential to advance health equity by improving access for underserved populations, including racial and ethnic minorities as well as rural residents.

Recent peer-reviewed studies, including the EARLY TAVR trial, demonstrate that early TAVR in asymptomatic severe AS patients reduces the composite endpoint of all-cause mortality, stroke, or unplanned cardiovascular hospitalization by 50% compared to clinical surveillance (hazard ratio, 0.50; 95% CI, 0.40-0.63). A meta-analysis of randomized trials further confirms reductions in all-cause mortality (RR 0.74, 95% CI 0.55-0.99) and cardiovascular hospitalizations (RR 0.48, 95% CI 0.39-0.58). These findings underscore the benefits of earlier intervention, particularly as TAVR technologies have evolved and favorable long-term outcomes have been scientifically demonstrated.

From a health equity perspective, racial and ethnic disparities in TAVR access are well-documented. Among Medicare beneficiaries, Black (HR 0.87, 95% CI 0.85-0.89), Hispanic (HR 0.92, 95% CI 0.88-0.96), and Asian (HR 0.95, 95% CI 0.91-0.99) patients are significantly less likely to receive aortic valve replacement within six months of AS diagnosis compared to White patients. While the causes of these disparities are multifactorial, "lack of symptoms" is frequently documented as a reason for not referring these patients for appropriate treatment. Expansion of the NCD to cover asymptomatic Aortic Stenosis would remove that limitation.

Moreover, rural populations face pronounced access disparities. Fewer than 5% of new TAVR programs between 2012 and 2018 opened in nonmetropolitan areas, with only one in a rural area, leading to significant geographic gaps. "No-TAVR zones" are predominantly rural (94.2%), characterized by lower population densities and higher area deprivation indices, resulting in delayed care and worse outcomes for these patients. This is undoubtedly related to volume requirements needed to maintain competency and deliver safe care. Paradoxically, these populations, often present with more advanced symptoms due to delayed diagnosis and limited access to specialized care, exacerbating outcomes. Expanding NCD coverage to asymptomatic patients would facilitate not only the volume growth necessary to develop and maintain procedural competency in those geographically disadvantaged regions, but also promote proactive screening and timely TAVR, mitigating these disparities by enabling intervention before symptom onset in high-risk groups.

This NCD expansion approach also aligns with sound health economics principles, as real-world data from over 24,000 patients show that prompt intervention in severe AS before symptoms develop results in significantly lower healthcare costs at one year ($36,000 less per patient), shorter hospital stays (2.2 fewer days), and 80% fewer follow-up heart failure hospitalizations. Delaying TAVR is associated with higher overall costs, emphasizing the economic value of early access.

By reducing long-term expenditures through fewer complications and improved quality of life, this expansion promotes equitable distribution of advanced cardiovascular therapies while yielding substantial savings for the Medicare system.

For these reasons I urge CMS to approve this expansion to ensure all patients, regardless of background or location, benefit from evidence-based TAVR advancements.

Less

TAVR has become a mature procedure that intrinsically is a single operator, as already performed worldwide (Europe,Canada, etc). Much more complex and risky procedures (such as complex PCI under Impella, complex mitral clip, and even open-heart surgery) do not mandate 2 operators and are done safely. The vast majority of complications (including bleeding, vascular complications) are managed via endovascular technic where the CT surgeon expertise is not required. More importantly, the very small numbers of more serious complications could be managed with prompt placement of ECMO, follow by conversion to open heart surgery if needed.
TAVR should be perform in center where CT surgery is available. Heart team discussion of complex patients, younger patients, or where anatomy is challenging should obviously happens and be preserved. However, mandating 2 operators is unnecessary and add important logistic challenges in getting patients scheduled and treated promptly. More importantly, appropriately trained operators (1-year dedicated fellowship) should be mandated for operators to be able to perform structural heart intervention, that are becoming more and more complex.
Some cases may require 2 operators, but that should be left at the discretion of the principal operator, and not a mandate.
Practically speaking, with the upcoming shortage of CT surgeons, and the emergence of more and more complex surgery, we need more than ever CT surgeons that know how to perform complex surgery, not implanting TAVR. The re-emergence of Ross, the need for democratization of root enlargement, and the growing field of TAVR explant require CT surgeons to spend more time in the Operating Room, and not waste their time as a second operators inflating/deploying a TAVR valve. Our patients need CT surgeon to be great CT surgeon.

Less

Public Comment on Medicare Coverage for Transcatheter Aortic Valve Replacement (CAG-00430R2)

Given the available evidence, I think it is hard to justify changing policy and covering TAVR for asymptomatic patients.

The best evidence is from TAVR trial (NEJM 2025). But I agree with the editorialist who said: "Although the EARLY TAVR trial provides compelling data that may shift the paradigm in managing asymptomatic severe aortic-valve stenosis, further studies are essential to delineate the subgroups of patients who would derive the most benefit from early intervention. This approach will ensure that the promise of TAVR is realized without compromising patient safety or resource allocation. Expanding early or preemptive interventional treatment to all asymptomatic patients who might formally meet hemodynamic and anatomical criteria may be premature. For now, awaiting symptoms remains a justifiable strategy."

The trial arguably supports the current strategy of waiting for symptoms in this population. TAVR for asymptomatic patients did not show an all-cause mortality benefit (RR 0.9 but very wide CI [0.6-1.4] which includes important benefit and harm), or a reduction in stroke (RR=0.6, CI 0.4-1.1). The positive finding (and the one that drove the composite outcome) was for a reduction in unplanned hospitalization for cardiovascular causes, which is problematic because it is a subjective measure adjudicated by a committee "whose members were aware of the treatment-group assignments” [TAVR trial, NEJM 2025].

TAVR may ultimately have a role for asymptomatic patients - but we just don’t know yet. Until we do, it is premature to change practice.

Steven Woloshin, MD, MS
Dartmouth Institute for Health Policy and Clinical Practice
and the Lisa Schwartz Foundation for Truth in Medicine

Less

Subject: Reconsideration of Medicare National Coverage Determination (NCD 20.32) for TAVR (CAG-00430R2)

Thank you for reopening the TAVR NCD to reflect evolving clinical evidence, including consideration of coverage for asymptomatic severe aortic stenosis and modernization of coverage conditions. Below are my thoughts on opportunities to optimize the ruling for our patients:

1) Expand Coverage to Include Asymptomatic Severe Aortic Stenosis, Aligned with FDA Labeling

Recent data (e.g., the EARLY TAVR program) and subsequent FDA label expansion for Sapien 3 indicate that early intervention in *asymptomatic* severe AS improves outcomes versus watchful waiting, primarily through reduced unplanned CV hospitalizations and signals toward lower all-cause mortality and stroke. CMS should reflect these data by extending coverage to asymptomatic severe AS when the patient meets FDA-authorized indications and Heart Team consensus.

2) Modernize “Coverage with Evidence Development” (CED) While Preserving Robust Outcomes Surveillance

NCD 20.32 currently requires registry participation and specific study parameters under CED. We support preserving national, audited outcomes tracking (e.g., continued use of the STS/ACC TVT Registry) while retiring CED for on-label indications with mature, high-quality evidence. This approach sustains transparency and quality improvement without imposing unnecessary administrative barriers that delay care.

3) Keep the Heart Team Framework, Streamline Pre-Procedure Evaluation

CMS’s 2019 update appropriately aligned the pre-procedure evaluation to one cardiac surgeon and one interventional cardiologist, reflecting contemporary Heart Team practice. CMS should retain this structure and explicitly support telehealth where appropriate for evaluations and follow-up in order to reduce delays, especially for patients traveling long distances.

4) Reduce Administrative Complexity & Align MA Processes

Hospitals face operational friction in documenting clinical trial/CED elements, coding, and prior authorization—particularly across Medicare Advantage plans. CMS can materially improve access and throughput by simplifying research/billing distinctions for on-label care and by encouraging MA plans to align authorization policies with the updated NCD.

5) Equity & Access Considerations

Severe AS is common, undertreated, and associated with avoidable morbidity/mortality. A modernized NCD should:

6) Implementation Guidance

When the final NCD is issued, please provide a clear transition plan to avoid disruption—especially for scheduling already queued asymptomatic severe AS patients and for registry reporting/MA prior authorization alignment.

Conclusion:
CMS’s reconsideration offers an important opportunity to align Medicare policy with current evidence, preserve safety through outcomes surveillance, and meaningfully expand access to timely, lifesaving TAVR care. I strongly support coverage for asymptomatic severe AS under FDA labeling, and modernization of CED.

Respectfully submitted,
Marco N. Diaz, MD
Chief Cardiovascular Services, MaineHealth

Less

January 14, 2026

Joanna Baldwin
Interim Director, Coverage and Analysis Group (CAG)
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

RE: Transcatheter Aortic Valve Replacement National Coverage Analysis - CAG-00430R2

Dear Ms. Baldwin,

On behalf of The Society of Thoracic Surgeons (STS), I write to provide comments on the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Analysis (NCA). Founded in 1964, STS is a not-for-profit organization representing more than 7,800 surgeons, researchers, and allied healthcare professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lungs, and esophagus, as well as other surgical procedures within the chest.

This document outlines key considerations regarding the evolving use of TAVR in the context of the current NCA. As access to TAVR expands, it is critical that coverage policy continues to prioritize patient safety and high-quality, evidence-based care. The following points summarize our positions.

• Completion of Coverage with Evidence Development (CED):
  CED should continue until there is adequate evidence to inform the lifetime management of patients with aortic stenosis (AS), including long-term outcomes, device durability, and the need for repeat interventions. As indications expand and treated populations and care settings evolve, continued participation in the STS/ACC Transcatheter Valve Therapy Registry™ (TVT-R) remains essential to generate real-world data that ensure coverage decisions keep pace with clinical practice and patient needs.
• Expanded TAVR Indications:
  We support a measured, evidence-based approach to treating asymptomatic AS. While emerging trial data suggests potential benefit in select patients, treatment should be limited to carefully defined populations evaluated by a multidisciplinary Heart Team, with shared decision-making and continued evidence development to avoid inappropriate expansion and overtreatment.
• Patient Access and Geographic Equity
  While limited geographic access to care issues exist, the priority should remain ensuring safe access to TAVR rather than decentralizing care. Maintaining established centers with multidisciplinary Heart Teams and on-site surgical backup is critical to protect patients, minimize procedural complications, and enable timely rescue in the event of adverse events.

Coverage with Evidence Development

STS has significant concern regarding the proposal to remove CED from the TAVR National Coverage Determination (NCD). While we recognize that, by law, CED is intended to sunset, STS does not believe that the current state of TAVR warrants the removal of this important safeguard. CED has played a critical role in ensuring patient safety by supporting the systematic collection of real-world evidence, monitoring outcomes, and identifying areas for improvement in TAVR procedures and technology innovation. Removing CED at this juncture will compromise our ability to assess expanded indications and detect emerging risks, address gaps in knowledge, and maintain the highest standards of care for Medicare beneficiaries. The removal of CED raises several critical issues, which we will detail in the following sections. We urge CMS to carefully consider the implications of this change for patient safety and the broader healthcare system.

Real-World Evidence Needed for New Indications

CMS is considering additional coverage for asymptomatic AS patients within the TAVR NCD due to evidence that early intervention of aortic valve replacement (AVR) reduces the risk of death, stroke, or unplanned cardiovascular hospitalization. While observations that some asymptomatic patients with severe AS may be at higher risk and benefit from early TAVR intervention, American College of Cardiology (ACC)/American Heart Association (AHA) clinical guidelines state that intervention is generally reserved for patients with left ventricle ejection fraction (LVEF) <50%, abnormal exercise test, or other high-risk features (e.g., very severe AS, rapid progression, elevated B-type Natriuretic Peptide (BNP)). Routine TAVR in asymptomatic patients is not recommended, underscoring the need for cautious, individualized, Heart Team-based decision making supported by prospective data collection.

The natural history of truly asymptomatic AS is characterized by a relatively low short-term mortality risk when patients are carefully monitored. Data from the Heart Valve Clinic demonstrate that among patients with asymptomatic aortic stenosis followed longitudinally, the annual rate of sudden cardiac death was approximately 2.5 per 1,000 patients, reflecting a very low absolute risk under contemporary management. These findings underscore that, in the absence of symptoms or high-risk features, watchful waiting with structured surveillance is a safe and effective strategy for many patients. If TAVR coverage is expanded beyond current guideline-supported indications, CED is necessary to distinguish patients who meaningfully benefit from early intervention from those for whom procedural risk (i.e., thrombosis, infection, prosthetic heart valve disease, and device failure) may outweigh the potential benefits.

Evidence supporting early TAVR in asymptomatic patients remains limited. The EARLY TAVR trial demonstrated a reduction in a composite endpoint driven largely by cardiovascular hospitalizations, but it did not show a reduction in all-cause mortality. The trial has also been subject to critique related to endpoint selection, crossover from surveillance to intervention, and questions regarding generalizability to routine clinical practice. These limitations are particularly important when considering patients outside the narrowly defined trial population, reinforcing the need for ongoing evidence generation through CED if coverage is broadened.

In the EARLY TAVR trial, early intervention reduced a composite endpoint driven largely by cardiovascular hospitalizations but did not reduce all-cause mortality. An accompanying editorial by Nishimura underscored this limitation, emphasizing that in the absence of symptoms, patients cannot experience symptomatic or quality-of-life improvement and therefore derive no perceptible benefit from early valve replacement. As noted in the editorial, intervening in asymptomatic patients raises fundamental questions when treatment neither prolongs life nor improves how patients feel. Importantly, the generalizability of the trial findings is further limited by restricted patient diversity, including the enrollment of relatively few women, a population known to have distinct valvular anatomy, presentation patterns, and outcomes following valve intervention. , CED would provide a valuable mechanism to address these evidence gaps by capturing outcomes across broader, more representative populations.

Other randomized evidence evaluating early intervention strategies in asymptomatic patients, such as the EVOLVED trial, failed to demonstrate a significant benefit on hard clinical outcomes, underscoring persistent uncertainty regarding optimal timing of intervention. Moreover, other trials frequently cited in support of early treatment, RECOVERY and AVATAR, evaluated surgical aortic valve replacement (SAVR) rather than TAVR. While these studies provide valuable insight into the potential role of early surgery in carefully selected patients, their findings cannot be directly extrapolated to transcatheter approaches, given meaningful differences in patient selection, procedural risk, durability considerations, and long-term management.

If CMS elects to include asymptomatic AS patients in the TAVR NCD, CED is necessary to ensure that expansion is guided by real-world evidence rather than a single trial with acknowledged limitations. Particular caution is warranted for patients outside the EARLY TAVR trial population, where uncertainty regarding benefit is greatest. Importantly, patient selection should be driven not by chronological age alone, but by projected life expectancy, comorbidity burden, and anticipated durability needs, factors best assessed by a multidisciplinary Heart Team. Continued CED would allow CMS to monitor outcomes, refine selection criteria, and ensure that early intervention improves survival and long-term patient-centered outcomes without exposing patients to unnecessary procedural risk.

Additionally, a California statewide analysis of AVR in patients =60 years old underscores why continued CED for TAVR is essential to protect patients in expanded populations. Using statewide administrative data from 2013–2021, investigators found that the use of TAVR in patients under 60 increased dramatically, from just over 7% to nearly 46% by 2021. This is despite professional guidelines recommending SAVR for younger, lower-risk patients due to concerns about long-term valve durability and lifetime management of aortic valve disease. This rapid expansion of TAVR in young patients reflects substantial off-label use of TAVR outside the populations studied in pivotal clinical trials, highlighting how quickly practice patterns can outpace the evidence base.

Importantly, the study did not merely document utilization trends, it demonstrated potential patient harm. In propensity-matched analyses, younger patients who underwent TAVR had worse long-term survival compared with those who received SAVR, raising serious concerns about exposing younger patients to therapies without adequate long-term data. These findings illustrate the very risk CED is designed to address; when coverage expands without ongoing evidence generation and guardrails, procedures may be used in populations where safety and effectiveness are uncertain, putting current and future Medicare beneficiaries at heightened risk. CED ensures that access to TAVR remains tied to systematic data collection, guideline-concordant decision-making, and continuous evaluation of outcomes, helping prevent inappropriate off-label use and safeguarding patients.

These concerns are further reinforced by national data from the TVT-R, which show that patients younger than 65 years represent a small but growing cohort of TAVR recipients in U.S. practice. Registry analyses indicate that these younger patients often have a higher burden of comorbidities and experience worse clinical outcomes compared with older TAVR patients. Taken together, the California and TVT-R findings demonstrate the critical role of CED in ensuring that access to TAVR remains linked to systematic data collection, guideline-concordant decision-making, and continuous outcome evaluation—particularly for younger patients, where inappropriate off-label use may have profound and lasting implications for patient safety and long-term outcomes.

Improve Access to Care through CED

Criticism that CED delays or restricts access to TAVR overlooks the critical role that CED plays in expanding access responsibly while protecting patient safety. The most effective way to identify, monitor, and address gaps in access to care is through systematic collection and analysis of real-world evidence. By capturing detailed data on patient characteristics, treatment patterns, outcomes, and site-level availability, CED enables policymakers and clinicians to accurately identify where disparities exist, assess whether access barriers are improving, and detect new or unforeseen challenges as clinical practice evolves. Without continued data collection, it becomes impossible to determine whether access concerns have truly been resolved or whether certain patient populations are being left behind, undermining efforts to ensure equitable care. Importantly, the history of TAVR demonstrates that CED and the TVT-R have facilitated, not hindered, innovation and access to break through technologies. The TVT-R has supported the safe adoption of successive generations of transcatheter valve technology, informed over 23 regulatory decisions, and enabled expansion of TAVR to broader risk populations based on high-quality evidence. Far from restricting care, CED has provided the framework that allowed TAVR to move rapidly from a niche therapy for high-risk patients to a widely available, lifesaving treatment while maintaining accountability and continuous quality improvement.

Concerns that CED limits access to care are not supported by current infrastructure data. There is only a modest differential between the number of hospitals performing TAVR and those only performing cardiac surgery nationwide, with approximately 870 TVT-R participating sites compared with 1,000 Adult Cardiac Surgery Database (ACSD) participants.

Additionally, concerns that geographic access to TAVR remains inadequate are not supported by available national data. An analysis of the TVT-R published in JAMA Cardiology demonstrated that access to TAVR centers is already widespread across the United States. Among patients who underwent successful TAVR, the median driving time to the implanting center was just 35 minutes (interquartile range, 20–70 minutes), indicating that the vast majority of patients are able to receive care within a reasonable travel distance. These findings suggest that TAVR availability largely parallels existing cardiac care infrastructure and that significant geographic access gaps are uncommon.

Experience from the expansion of other advanced cardiac services further supports this conclusion. Data from the National Cardiovascular Device Registries and related geographic analyses of Percutaneous Coronary Intervention program growth show that new procedural centers frequently open in close proximity to existing facilities, concentrating capacity in already well-served markets and yielding only modest gains in population access. This pattern suggests that indiscriminate expansion of TAVR sites is unlikely to meaningfully improve geographic access, while risking dilution of procedural volume and fragmentation of multidisciplinary care.

This demonstrates that TAVR access is broadly aligned with existing cardiac care capacity and that CED requirements have not created a significant structural barrier to care. In fact, rather than slowing adoption, CED has facilitated and accelerated the responsible diffusion of TAVR by providing a clear, transparent framework that supported regulatory confidence, informed successive coverage expansions, and enabled timely access for eligible patients as evidence matured. Taken together, these considerations underscore that CED is not a mechanism to delay treatment, but rather a proven approach to expand access thoughtfully, identify and correct disparities, and ensure that patients receive evidence-based, high-quality care as technology and indications continue to evolve.

To further reduce any perceived burden associated with CED data collection for participating hospitals, STS and ACC have implemented ongoing processes to minimize data collection demands while preserving data quality and clinical value. The STS and ACC regularly review and refine the TVT-R case report forms to identify opportunities to eliminate low-value data elements, streamline workflows, and align registry requirements with evolving clinical practice and regulatory needs.

In parallel, the registries are working with partners to develop technology-enabled solutions that automate data abstraction directly from electronic health records (EHRs), reducing the need for manual data entry and associated staff time. Together, these initiatives ensure that participation in CED remains efficient and sustainable for hospitals, while continuing to generate high-quality real-world evidence that supports patient safety, program oversight, and responsible innovation in TAVR care.

Public Safety at Risk for Medicare Beneficiaries

Beyond issues of access, eliminating CED poses significant risks to patient safety, particularly for a complex, rapidly evolving technology such as TAVR as clinical indications continue to expand. Although transcatheter aortic valves have not been subject to a device recall to date, the history of cardiac implantable devices demonstrates why continued, systematic surveillance is essential when novel technologies are applied to broader and lower-risk populations. The Government Accountability Office analyses of high-risk medical technologies showed that cardiovascular devices like heart valves and pacemakers represented 16% of all medical device recalls between 2020-2024, the highest of any one medical specialty area. As TAVR use moves beyond its original, higher-risk populations and into new indications such as asymptomatic aortic stenosis, CED provides the critical infrastructure needed to detect early safety signals related to device performance, durability, or failure in real-world practice. Without a robust national evidence framework like CED, emerging risks may be identified too late, potentially exposing large numbers of patients to avoidable harm and undermining confidence in responsible technology adoption.

These risks are amplified by growing concerns about lifetime valve management, especially in younger and lower-risk patients. Emerging evidence suggests that valve-in-valve strategies may not provide durable long-term solutions, as second valves often demonstrate reduced lifespan and higher risk of patient-prosthesis mismatch. , Data also indicate that a treatment sequence of TAVR followed by SAVR may be detrimental, with more complex surgery and worse outcomes compared with initial SAVR in appropriate patients. Consistent with these concerns, surgical aortic valve replacement after prior TAVR is now the fastest growing reoperative valve procedure captured in the ACSD. These trends underscore the need for continued, systematic data collection to better understand long-term outcomes, procedural sequencing, and the true lifetime implications of early TAVR use.

Public safety concerns are further heightened by recent policy shifts, including the elimination of the inpatient-only (IPO) list in the CMS Federal Year 2026 Inpatient Prospective Payment System final rule. STS has significant concerns with the finalization of the IPO list and the momentum that allows for the potential expansion of TAVR into ambulatory surgical centers that may lack on-site surgical backup. As TAVR moves into lower-acuity environments, the risk of fragmented care and delayed rescue in the event of catastrophic complications increases. Notably, recent data demonstrate that lowering procedural volume thresholds and moving away from coordinated Heart Team–based care are associated with higher complication rates and worse patient outcomes. These findings directly reinforce the rationale underlying the TAVR multi-society consensus statement, which established minimum institutional and operator volume requirements to ensure adequate experience, team readiness, and infrastructure for managing procedural complexity and complications. The consensus statement volume requirements are not arbitrary barriers to access, but evidence-informed safeguards designed to preserve quality and patient safety as TAVR is adopted across diverse care settings. Maintaining these programmatic requirements is essential, particularly as TAVR expands into new indications and lower-risk populations.

Preservation of the multidisciplinary Heart Team model is therefore essential to maintaining high-quality, patient-centered care as TAVR use continues to expand. The Heart Team unites cardiac surgeons, interventional cardiologists, imaging experts, anesthesiologists, and other cardiovascular clinicians to support thoughtful, guideline-aligned patient selection. This multidisciplinary approach also enables careful procedural planning for complex anatomy and long-term valve management, while ensuring that potential complications are addressed efficiently through coordinated access to the full range of cardiovascular expertise. Importantly, this collaborative model has been central to the successful development and diffusion of TAVR itself, serving as a historical example of how novel cardiovascular devices can be safely introduced through rigorous evidence generation, registry-based oversight, and shared clinical accountability. This is particularly critical as TAVR is considered for younger patients, anatomically challenging conditions, and emerging indications where the balance of risks and benefits may be less certain and long-term implications are substantial. Continued CED provides the infrastructure needed to capture outcomes across care settings, monitor safety as practice patterns evolve, and ensure that expanded access does not come at the expense of patient safety.

New Technology Becoming Available

As new transcatheter technologies continue to emerge, CED becomes increasingly essential to ensure patient safety and optimize clinical outcomes. For example, trials are now evaluating TAVR in patients with bicuspid aortic valves, a population historically excluded from pivotal TAVR studies due to anatomic complexity and concerns about procedural durability and complications. Systematic real-world evidence collection is critical in this context to monitor device performance, procedural success, and long-term outcomes outside the controlled trial environment, providing insights into the safety and effectiveness of TAVR in anatomically challenging patients.

Similarly, novel transcatheter devices to treat aortic regurgitation are entering clinical development and early adoption. Unlike stenotic valves, aortic regurgitation presents unique hemodynamic challenges that may influence valve seating, paravalvular leak, and long-term durability. Without the structured oversight and data capture afforded by CED, it would be difficult to identify early safety signals, procedural limitations, or patient selection criteria necessary to guide broader adoption. In both scenarios, CED ensures that the introduction of innovative therapies is accompanied by rigorous outcome monitoring, continuous quality improvement, and evidence-based decision-making, protecting patients while supporting responsible innovation in structural heart disease.

STS strongly urges CMS to maintain CED for TAVR. CED has been essential for safeguarding patient safety, supporting systematic data collection, and guiding responsible expansion of TAVR to new populations. Removing CED now could compromise the ability to monitor outcomes, address emerging risks, and ensure equitable access to high-quality care. As TAVR indications and technologies continue to evolve, ongoing evidence generation remains critical to protect patients and support innovation. Ongoing evidence generation supports best practices for structural heart disease management.

Thank you for considering these comments. We appreciate CMS’s consideration and remain committed to collaborating on policies that guarantee safe, effective, and accessible aortic valve therapies for all patients.

For additional information or clarification, please contact Molly Peltzman, Associate Director of Health Policy, at mpeltzman@sts.org.

Sincerely,
Joseph F. Sabik III, MD
President
The Society of Thoracic Surgeons

1. Lindman, B, Dweck, M, Lancellotti, P. et al. Management of Asymptomatic Severe Aortic Stenosis: Evolving Concepts in Timing of Valve Replacement. J Am Coll Cardiol Img. 2020 Feb, 13 (2_Part_1) 481–493.
2. https://doi.org/10.1016/j.jcmg.2019.01.036
3. Lancellotti P, Magne J, Donal E, et al. Outcomes of patients with asymptomatic aortic stenosis followed up in heart valve clinics. JAMA Cardiol. 2018;3(11):1060-1068. doi:10.1001/jamacardio.2018.3152
4. Généreux P, Schwartz A, Oldemeyer JB, et al; EARLY TAVR Trial Investigators. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med. 2025;392(3):217-227. doi:10.1056/NEJMoa2405880
5. Nishimura RA. Early transcatheter aortic-valve replacement for asymptomatic aortic stenosis—proceed with caution. N Engl J Med. 2025;392(3):287-289. doi:10.1056/NEJMe2409911
6. Généreux P, Schwartz A, Oldemeyer JB, et al; EARLY TAVR Trial Investigators. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med. 2025;392(3):217-227. doi:10.1056/NEJMoa2405880
7. Chandrasekhar J, Dangas G, Mehran R. Sex differences in aortic stenosis and transcatheter aortic valve replacement. J Am Coll Cardiol. 2017;69(22):2733-2748. doi:10.1016/j.jacc.2017.03.552
8. Loganath K, Craig NJ, Everett RJ, et al. Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis: The EVOLVED Randomized Clinical Trial. JAMA. 2025;333(3):213-221. doi:10.1001/jama.2024.22730
9. Ahmad Y, Howard JP, Seligman H, et al. Early Surgery for Patients With Asymptomatic Severe Aortic Stenosis: A Meta-Analysis of Randomized Controlled Trials. J Soc Cardiovasc Angiogr Interv. 2022;1(4):100383. Published 2022 May 25. doi:10.1016/j.jscai.2022.100383
10. Egorova N, et al. Guidelines vs Practice: Surgical Versus Transcatheter Aortic Valve Replacement in Adults =60 Years. Analysis of California Department of Health Care Access and Information data showed TAVR use in patients aged =60 increased from 7.2% in 2013 to 45.7% in 2021. Published 2025.
11. Coylewright M, Grubb KJ, Arnold SV, et al. Outcomes of Balloon-Expandable Transcatheter Aortic Valve Replacement in Younger Patients in the Low-Risk Era. JAMA Cardiol. 2025;10(2):127-135. doi:10.1001/jamacardio.2024.4237
12. Marquis-Gravel G, Stebbins A, Kosinski AS, et al. Geographic access to transcatheter aortic valve replacement centers in the United States: insights from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. JAMA Cardiol. 2020;5(9):1-6. doi:10.1001/jamacardio.2020.1725
13. Vemulapalli S, Dai D, Mulukutla S, et al. Hospital procedural volume and outcomes of percutaneous coronary intervention in the United States: insights from the NCDR CathPCI Registry. Circulation. 2016;134(1):55-64. doi:10.1161/CIRCULATIONAHA.115.019839
14. https://files.gao.gov/reports/GAO-26-107619/index.html?_gl=1*17pw1d8*_ga*MjA0NjcwNzIyOS4xNzY2MDgxMDQ2*_ga_V393SNS3SR*czE3NjYwODEwNDYkbzEkZzEkdDE3NjYwODEwNjckajM5JGwwJGgw
15. Herrmann, H, Daneshvar, S, Fonarow, G. et al. Prosthesis–Patient Mismatch in Patients Undergoing Transcatheter Aortic Valve Replacement: From the STS/ACC TVT Registry. JACC. 2018 Dec, 72 (22) 2701–2711.
16. https://doi.org/10.1016/j.jacc.2018.09.001
17. Testa L, Casenghi M, Criscione E, et al. Prosthesis-patient mismatch following transcatheter aortic valve replacement for degenerated transcatheter aortic valves: the TRANSIT-PPM international project. Front Cardiovasc Med. 2022;9:931207. Published 2022 Jul 29. doi:10.3389/fcvm.2022.931207
18. Jawitz OK, Gulack BC, Grau-Sepulveda MV, et al. Reoperation After Transcatheter Aortic Valve Replacement: An Analysis of the Society of Thoracic Surgeons Database. JACC Cardiovasc Interv. 2020;13(13):1515-1525. doi:10.1016/j.jcin.2020.04.029
19. Bowdish ME, Habib RH, Kaneko T, Thourani VH, Badhwar V. Cardiac Surgery After Transcatheter Aortic Valve Replacement: Trends and Outcomes. Ann Thorac Surg. 2024;118(1):155-162. doi:10.1016/j.athoracsur.2024.03.024
20. Kumbhani DJ, Girotra S, Dong H, et al. Contemporary Operator Procedural Volumes and Outcomes for TAVR and MTEER in the US. JAMA Cardiol. Published online January 08, 2026. doi:10.1001/jamacardio.2025.5645
21. Bavaria JE, Tommaso CL, Brindis RG, et al. 2018 AATS/ACC/SCAI/STS expert consensus systems of care document: operator and institutional recommendations and requirements for transcatheter aortic valve replacement. J Am Coll Cardiol. 2019;73(3):340-374. doi:10.1016/j.jacc.2018.07.002
22. Halim SA, Edwards FH, Dai D, et al. Outcomes of Transcatheter Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Disease: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circulation. 2020;141(13):1071-1079. doi:10.1161/CIRCULATIONAHA.119.040333
23. https://www.acc.org/Latest-in-Cardiology/Clinical-Trials/2025/03/27/17/51/align-ar
24. Brouillard P, Diallo EH, Ben Ali W, Kouz R. The Next Chapter in TAVR: Innovations and the Road Ahead. J Clin Med. 2025 Jun;14(13):4504. doi: 10.3390/jcm14134504. PMID: 40648878; PMCID: PMC12249560.

Less

1) Role of TAVR in Asymptomatic Severe AS

Recent evidence clearly demonstrates the benefit of aortic valve replacement for patients with asymptomatic severe AS, including evidence supporting surgical AVR(1-4), and including evidence supporting TAVR(3-5). The totality of evidence demonstrated benefits and lack of penalty/harm with a strategy of early intervention compared to “watchful waiting”, whether it is done with TAVR or SAVR. Recent 7-year data comparing TAVR to SAVR are reassuring for severe AS patients with symptoms in terms of clinical outcomes including death, stroke and need for reintervention(6), and the decision of whether a patients with Asymptomatic Severe AS should have TAVR or SAVR should be based on the Heart Team discussion, including anatomy considerations, life expectancy, lifetime management of multiple potential procedures, and patient preferences.

The EARLY TAVR demonstrated the superiority of an early TAVR strategy compared to clinical surveillance in terms of the composite of death, stroke, and unplanned cardiovascular hospitalization (50% reduction), and additional endpoints including the composite of death, stroke, and heart failure (40% reduction), and the composite of death, stroke, and intervention in the context of acute valve syndrome (acute decompensation such as NYHA 3-4, pulmonary edema, syncope, cardiac arrest; 50% reduction), at a median follow-up of 3.8 years(5). Those results were reiterated in a recent meta-analysis of the 4 published RCTs(3), showing significant reduction in heart failure hospitalization (70%), and significant reduction in stroke rate (40%). When summarizing the totality of the evidence including real world data, the benefits of early intervention (TAVR or SAVR) extend to a benefit in survival favoring early intervention(4). No benefits were derived for a waiting strategy, and no penalty were demonstrated with a strategy of early intervention, making early intervention (either TAVR or SAVR), the preferred strategy for managing patients with severe AS with no symptoms. Those recent finding actually lead to the European guidelines 2025 (ESC/EACTS) to upgrade TAVR (similar to SAVR) to a Class 2A Level of evidence A for the management of Asymptomatic severe AS.(7)

Multiple sub-analysis of the EARLY TAVR trial also demonstrated consistent benefits of a strategy of early intervention with TAVR among multiple subgroups, including patients with or without elevated biomarkers(8), age (Genereux/Goel et al. SCAI 2025), sex, or extent of cardiac damage/LV health(9). The clinical benefits of EARLY TAVR was consistent among all pre-specified sub-groups.

More importantly, the EARLY TAVR, similar to the seminal paper published by Otto et al in 1997(10), demonstrated that ~50% of patients with Asymptomatic severe AS will convert to symptoms and require AVR within 1 year of diagnosis, and ~75% at 2 years post diagnosis(5). Those findings are important and illustrate that severe AS is a progressive disease, with patients experiencing symptoms quickly after diagnosis, and where the consideration of waiting to avoid the need for multiple interventions (multiple valve) is irrelevant and inappropriate.

Similarly, the EARLY TAVR and subsequent analyses demonstrated that the first mode of clinical presentation was acute/severe and advanced symptoms, with >40% of patients randomized to clinical surveillance in EARLY TAVR converting to either NYHA 3-4 heart failure (30%), syncope (7%), pulmonary edema or cardiac arrest. This mode of conversion called “Acute Valve Syndrome” (AVS), was associated with worse outcomes, including increase stroke risk, and death and heart failure in the future(11-13). It was also not possible to identify predictor of acute or severe symptoms, highlighting how unpredictable the progression of AS to symptoms is. When looking at real-world data, among more than 27,000 patients undergoing TAVR or SAVR, the mode of presentation before AVR was in ~60% acute valve syndrome, which was associated with 3x increase mortality and 4x increase in heart failure hospitalization post AVR at 2 years, compared to patients intervened when asymptomatic(12). Additionally, another recent analysis assessing real world data demonstrated that AVR (TAVR or SAVR) performed in the context of advanced and acute symptoms was associated with significant increase in health care costs and resources use 1 year post AVR, with patients intervened while presenting with AVS being associated with ~$36,000 increase in cost compared to asymptomatic patients, and patients presenting with mild symptoms (NYHA 2) before AVR being associated with ~$27,000 more compared to patients undergoing AVR while being asymptomatic(14). The difference was mainly driven by increase length of stay of the index procedure and the increase in heart failure re-hospitalization. In summary, those studies demonstrated that AVS was frequent among patients undergoing AVR (both in RCTs trials and real world) and was associated with increase in death, heart failure hospitalization, stroke, health care costs, and resource use 1 year after AVR. Intervention among patient with no symptoms and stable presentation was associated with the best clinical and economic outcomes. Based on the totality of those findings, clinical surveillance or watchful waiting for Asymptomatic severe AS should not be the default strategy anymore, and prompt referral, assessment, and treatment, with SAVR or TAVR, should become the new standard of care.

Reimbursing TAVR for Asymptomatic AS patients is crucial to ensure optimal outcomes for our patients, avoiding dramatic clinical presentation associated with waiting, and ensure a reduction in health care cost and resources use.

1. Kang DH, Park SJ, Lee SA et al. Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis. N Engl J Med 2020;382:111-119.
2. Banovic M, Putnik S, Da Costa BR et al. Aortic valve replacement vs. conservative treatment in asymptomatic severe aortic stenosis: long-term follow-up of the AVATAR trial. Eur Heart J 2024;45:4526-4535.
3. Genereux P, Banovic M, Kang DH et al. Aortic Valve Replacement vs Clinical Surveillance in Asymptomatic Severe Aortic Stenosis: A Systematic Review and Meta-Analysis. J Am Coll Cardiol 2025;85:912-922.
4. Genereux P, Banovic M, Kang DH et al. Aortic Valve Replacement in Asymptomatic Severe Aortic Stenosis: A Systematic Review and Meta-Analysis. J Soc Cardiovasc Angiogr Interv 2025;4:103663.
5. Genereux P, Schwartz A, Oldemeyer JB et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med 2025;392:217-227.
6. Leon MB, Mack MJ, Pibarot P et al. Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years. N Engl J Med 2025.
7. Praz F, Borger MA, Lanz J et al. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J 2025;46:4635-4736.
8. Lindman BR, Pibarot P, Schwartz A et al. Cardiac Biomarkers in Patients With Asymptomatic Severe Aortic Stenosis: Analysis From the EARLY TAVR Trial. Circulation 2025;151:1550-1564.
9. Lindman BR, Pibarot P, Schwartz A et al. Left Ventricular Health and TAVR Timing in Asymptomatic Severe Aortic Stenosis: Analysis From the EARLY TAVR Trial. J Am Coll Cardiol 2025.
10. Otto CM, Burwash IG, Legget ME et al. Prospective study of asymptomatic valvular aortic stenosis. Clinical, echocardiographic, and exercise predictors of outcome. Circulation 1997;95:2262-70.
11. Genereux P, Lindman BR, Pibarot P. New Classification to Describe Clinical Presentation in Aortic Stenosis: Stable, Progressive, and Acute Valve Syndrome. Circulation 2025;151:1627-1629.
12. Genereux P, Pellikka PA, Lindman BR et al. Acute Valve Syndrome in Aortic Stenosis. Struct Heart 2025;9:100377.
13. Genereux P, Schwartz A, Pibarot P et al. Outcomes of Early vs Delayed Aortic Valve Replacement: Analysis of the EARLY TAVR Valve Implant Population. JACC Cardiovasc Interv 2025;18:2761-2773.
14. Genereux P, Giustino G, Lindman BR et al. Acute Valve Syndrome Before Aortic Valve Replacement: Impact on Clinical Outcomes, Health Care Costs, and Resource Use. J Am Heart Assoc 2025;14:e043486.

Less

RE: National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (CAG-00430R2)

January 14, 2026

JoAnna Baldwin
Acting Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services (CMS)
Department of Health and Human Services
Attention: CAG-00430R2

Dear Ms. Baldwin:

On behalf of Medtronic, I am pleased to respond to the Centers for Medicare & Medicaid Services’ (CMS’s) request for public comment on the second reconsideration of the national coverage determination (NCD) for transcatheter aortic valve replacement (TAVR) in the treatment of aortic stenosis (AS). (1, 2, 3)

Medtronic is the world’s leading medical technology company, specializing in implantable and interventional therapies that alleviate pain, restore health, and extend life. As a global leader in both surgical and transcatheter heart valve therapies, including the CoreValve™ and Evolut™ transcatheter aortic valves, Medtronic maintains a robust technology and clinical development program on TAVR and we are committed to delivering meaningful, evidence-based solutions across the care continuum to provide the best possible outcomes for heart valve patients around the world.

Medtronic supports CMS’s goals of supporting patient access to therapies that improve health outcomes in the Medicare population. In general, we believe the broad framework of the existing TAVR NCD including its revision in 2019 has been successful, enabling patient access to TAVR therapy while achieving high quality outcomes. We are pleased to offer comments to refine and improve TAVR coverage for Medicare beneficiaries.

We believe strongly in the following principles:

• Medicare’s coverage and payment policies should align and focus on providing access to TAVR therapies to patient populations as appropriate, particularly those in underserved communities, and encouraging the role of multidisciplinary heart teams in developing and following through on comprehensive treatment plans.
• Comprehensive evidence and professional consensus should continue to drive Medicare’s coverage of TAVR regardless of indication and Medicare should rely on the most updated guidelines.
• Medicare’s institutional and physician requirements for TAVR programs have served as the foundation for high quality care. TAVR programs with higher procedural volume produce better patient outcomes compared to lower-volume centers. Not only do the requirements in the TAVR NCD promote high quality care for TAVR patients, but they also provide an underlying foundation for the provision of high quality care in hospitals that provide other transcatheter structural heart therapies. Any changes to these requirements in the TAVR NCD must carefully consider the impact on the quality of care provided both for TAVR and across the transcatheter structural heart space.

The evolution of Medicare coverage of TAVR through the NCD and CMS’ ability to issue coverage for other structural heart therapies are clear examples of the successful execution of these principles. As described in detail in CMS’ own analysis of TAVR in the 2019 Decision Memo, such coverage of TAVR has enabled access and improved patient outcomes since 2012. (2)

Our comments focus on the following elements of the TAVR NCD:

• Access to Care: Medtronic is firmly committed to improving therapy access among AS patients, particularly those in underserved communities who have in large part been understudied and overlooked in outreach efforts to increase awareness through referrals. We believe that new initiatives that heighten patient awareness, educate patients on available treatments for AS, and strengthen referral networks can help ensure wider patient access to high quality TAVR therapy, rather than simply establishing new sites for TAVR care. We further believe that access is more effectively achieved through intentionally expanding and focusing research so that clinical study populations are appropriately heterogeneous and balanced.
• Multi-Disciplinary Heart Team: The involvement of interventional cardiology and cardiac surgery is foundational to the concept of multidisciplinary teams for TAVR implant procedures. Medtronic believes consultation with the multi-disciplinary heart team (MDHT) will ensure appropriate selection of treatment approaches across structural heart therapies, shared decision-making, and optimal outcomes for the patient. Both guidelines and collaboration with the MDHT inform referring physicians’ management of their patient populations and can ensure post-procedural continuity of care. Furthermore, continued joint participation of two operators during the procedure should be dictated by patient needs and the shared decision-making of the MDHT to ensure that TAVR patients receive the highest quality care for their situation and are not limited in their care options.
• Indications: Updates to covered indications must be driven by comprehensive evidence and professional consensus. Patient access and advancement in indications dually benefit from trials that are rigorous and representative in their design and execution. Previously approved TAVR indication expansions have occurred across multiple trials, populations, and devices. The rigor of these trials has driven clinical confidence and consensus on the benefits of TAVR in the studied populations. Medtronic believes that further trial experience, professional consensus, intentional recruitment of underserved populations, and ongoing evidence development is necessary to confirm the results of a single adequately powered trial targeting asymptomatic AS and establish with greater rigor and confidence the benefits in the expansion population. CMS should continue with a careful, stepwise approach to expanding coverage that relies on comprehensive evidence and consensus-based professional practice guidelines to ensure patient access is reasonable and necessary for the Medicare population across the spectrum of AS. Where the evidence is incomplete, further evidence development may be necessary to address open questions and confirm long-term results.
• Hospital and Physician Experience Requirements: Medicare’s institutional, physician, and heart team requirements for TAVR programs serve as the foundation for high quality care for all patients with heart valve disease. Changing these prematurely could place all patients with valve disease at risk. Medtronic urges CMS to maintain its vital role in partnership with clinicians to ensure best practices continue as patient access grows including beyond the symptomatic AS population and the existing centers which perform the procedure. Professional consensus and evidence-based guideline updates, expected in late 2026 or early 2027, should be a key input to any consideration of altering these requirements and should remain a reference point in Medicare coverage policy. We urge CMS to delay this reconsideration until those updates are available.
• Evidence Development and the TAVR Registry: Continued evidence development, including required reporting through the TVT registry, is critical, given open questions about populations and program requirements that could jeopardize quality of care. Given the limitations of available evidence and uncertainty about key questions on both expanded indications and potential changes in hospital/physician/heart team program requirements, conclusions regarding whether coverage policy changes in these areas are fully reasonable and necessary cannot be made. In such instances, CED would remain appropriate. The STS/ACC TVT Registry has been an essential mechanism to collect evidence and expand the knowledge base on TAVR therapies in the context of CMS’ coverage to date, and it should remain in place to address uncertainties posed by the contemplated revisions to the TAVR NCD. As CMS reconsiders the covered patient indications for TAVR and the physician and hospital requirements for the provision of TAVR procedures, any potential changes to the existing coverage policy will introduce a variety of new questions about the impact of the coverage revisions, including long-term evidence on the benefit of TAVR to asymptomatic patients and the quality of outcomes in new facilities if physician/operator/institutional requirements are revised. CED would be an appropriate and necessary mechanism to address these questions.

We offer more detail regarding our views on these five topics below.

Access to Care

Medtronic is firmly committed to improving therapy access among AS patients, particularly those in underserved communities who have in large part been understudied and overlooked. We believe that such access is achieved through extensive and targeted outreach efforts from awareness of AS to diagnosis through referrals for appropriate therapy. We further believe that such access is achieved through intentionally expanding and focusing research so that clinical study populations are appropriately heterogeneous and balanced.

Examination of current practice patterns demonstrate that there is significant opportunity to improve patient access within the TAVR site requirement framework that exists today, considering the overlap that exists between hospitals that provide TAVR and those that provide SAVR, and access to appropriate valve therapy is not necessarily dictated by proximity to either. Recent publications have identified areas of low- or no- TAVR access for Medicare beneficiaries [4, 5]; however, these studies do not fully reflect the approximately 850 hospitals now performing TAVR. To bring these analyses up to date and to also see the degree to which potential new sites might expand access, Medtronic analyzed Medicare utilization from FY 2023 to identify hospitals with TAVR programs and hospitals performing 40 or more open heart surgery cases but no TAVR cases as hospitals that may have the capabilities to initiate a TAVR program (e.g., open heart surgery experience and ability to form a multi-disciplinary heart team).? We then compared the geographic locations of these centers with the “low-TAVR” and “no-TAVR” zones identified by?David, et al. 2025?and found that the potential new TAVR hospitals generally do not fall in the high need zones without TAVR access identified by researchers. This analysis demonstrates that access to TAVR, especially for patients in those high need zones, needs to be driven through multi-channel educational efforts with intentional outreach to historically underserved populations. Direct-to-patient outreach from call centers, digital communications and focused engagements with relevant community-based organizations can all contribute to improved treatment rates within the existing program footprint.

Accordingly, new initiatives that heighten patient awareness and education of available treatments for AS and strengthen referral networks can help ensure wider patient access to high quality TAVR therapy. Patients, caregivers, and referring physicians can all benefit from improved awareness of TAVR programs within their communities. Connecting these patients to TAVR programs, however, requires a greater focus on heart valve disease among referring physicians and on-going education for echocardiologists and sonographers on accurate diagnosis of valvular disease. For example, female patients are at larger risk of being underdiagnosed based on a higher propensity to present with low-flow, low-gradient patterns that are at times mistaken for less severe stages of AS. Research shows that women are less likely to receive AVR treatment for symptomatic severe aortic stenosis than men. (6) Medtronic aims to close this gap with targeted patient access and valve education programs, partnerships, and sponsorships, including Women’s Heart Health Day on Capitol Hill, TAVRforwomen.com, and WomenwithAS.com. Our partnerships on these initiatives provide an opportunity to share resources and engage with clinicians, patients and community advocates on our therapy and activities supporting therapy access for women with AS.

Medtronic has also launched direct-to-patient (DTP) initiatives such as our “Letter to My Mother” awareness campaign to call attention to the threat of heart disease for women. Heart diseases remains the leading cause of death, with more than 60 million women in the U.S. living with some form of it, and yet heart disease is vastly undertreated in women. Advancing health equity is foundational to Medtronic’s mission in structural heart disease. Our approach is built across the full continuum of care, strengthening health systems, broadening evidence generation, and improving patient awareness and access. To help ensure more patients are identified and treated earlier, we are enhancing heart team and health system capabilities through innovations such as the ALERT study, which uses AI-powered patient identification to uncover undiagnosed heart valve disease and enable timely intervention. These initiatives are vital as areas that currently appear to have little or no TAVR utilization also may not have hospitals with the capabilities to start a TAVR program (e.g., open heart surgery experience).

We are equally committed to expanding diversity in clinical research so that evidence better reflects real-world patient populations. As recently as January 2026, in discussing the need for increased heterogeneity and balance in clinical study populations, a group of clinical experts pointed to transcatheter heart valves as case study where the evidence base was expanding to reflect more women. (7) They noted that while men are more frequently enrolled than women in clinical trials studying TAVR for treatment of severe AS, meta-analyses showed differential results by sex, and that patient-prosthesis mismatch is more frequently observed in women. The authors point to Medtronic’s Small Annuli Randomized to Evolut or SAPIEN Trial (SMART) trial as an example of a how the evidence base is expanding to include more women. The SMART trial is the largest randomized, controlled TAVR trial to enroll primarily women, providing clinicians with valuable insights to support more personalized treatment decisions. Medtronic is also working to increase participation from underrepresented communities in clinical studies in partnership with the American College of Cardiology’s REACH (Research, Equity, and Access for Cardiac Health) program. These efforts collectively reflect Medtronic’s commitment to expanding the evidence base to include historically underrepresented populations, thereby driving better patient outcomes. Comparable efforts must be made even more broadly to expand access to TAVR further.

In summary, we believe that appropriate access to TAVR is the result of a multitude of factors, driven by providing AS patients with the education and referral networks they need to access a qualified heart team and heart program for appropriate diagnosis, treatment, and follow-up, not simply a matter of increasing the number of sites that can provide TAVR.

Multi-Disciplinary Heart Team (MDHT)

Medtronic supports the continuation of multi-disciplinary heart teams (MDHT) in the pre- and post-operative care involved with TAVR, as this shared decision making will better ensure an appropriate choice of structural heart treatment and drive optimal outcomes, as well as the integration of SAVR experience with TAVR program requirements as an important feature to ensure excellent TAVR outcomes. We also continue to believe that it is critical that Medicare coverage and payment continue to allow equitable access to all treatment options based on patient need and, relatedly, the number of operators required to perform the procedure. Specifically, we encourage CMS to take into consideration feedback from the clinical community regarding whether two operators should be required in all cases. Just as importantly, however, CMS must continue to support coverage and payment of encounters when an individual patient’s clinical characteristics and care plan do require two operators.

With respect to pre- and post-operative care, the most recent professional consensus is clear that the involvement of cardiac surgery and cardiology as a joint institutional base is foundational to the concept of multidisciplinary teams for TAVR. (8) Furthermore, the most recent evidence-based guidelines also clearly assert the need for assessment of the patient by a multidisciplinary team (9). CMS refers to both of these in its own determination that these teams are necessary in its 2019 NCD of TAVR. (2) To amplify these consensus and guideline documents, the 2021 International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) disclosure statement regarding TAVR and SAVR in low and intermediate risk patients also point out that an MDHT is necessary for assessing patients, with one author commenting that ”…rather than relying on sophisticated risk scores and models, a back-to-basics approach with the use of multidisciplinary heart team... is the most appropriate way to assess our patients going forward.” (10) The importance of cardiac surgeons in evaluating patients’ suitability for TAVR and participating in shared decision-making is heightened in the context of indication expansion to include asymptomatic AS patients, as SAVR is still the consensus recommendation for this population.

Furthermore, SAVR experience, including the availability of cardiac surgeons and their participation as key members of the MDHT, remains a critical programmatic component to ensure best possible outcomes for TAVR. A 2019 analysis of Medicare fee-for-service beneficiaries receiving aortic valve replacements between 2012 and 2015 showed that receiving TAVRs at hospitals with lower SAVR volumes was associated with higher 30-day and 1-year mortality, suggesting the criticality of a viable surgical program and presence within the heart team. (11) A 2022 analysis of all-payer data from 2012 to 2018 yielded similar findings when examining the impact of SAVR volume on TAVR outcomes. (12) This study also found that SAVR experience was associated with improved TAVR outcomes (i.e., mortality and complications) for the cohort they identified from 2015 to 2018 but not the 2012 to 2015 cohort. The authors suggest that continued collaboration between cardiologists and surgeons is needed for optimal patient outcomes.

Finally, the ability for continued joint participation of two operators and others during the procedure as dictated by patient needs and the assessment of the MDHT is necessary to ensure that TAVR patients have access to the full range of care options in order to achieve optimal outcomes. Again, we reiterate that CMS should look to the clinical community in determining whether two operators should be required for performance of all TAVR cases. While this absolute requirement may no longer be necessary, we strongly urge CMS to make clear that coverage and payment remains in place for both physicians when clinically appropriate to meet individual patients’ needs, thereby ensuring access to the full range of technologies so all patients can have access to the right valve at the right time. CMS’s coverage of two operators also allows patients to benefit from the full range of expertise that a MDHT offers. As Medicare considers this requirement, hospitals, particularly those with smaller volumes and newer TAVR programs, will also need to evaluate the risks of abandoning the joint operator model.

Overall, we believe consultation with the MDHT, including the cardiac surgeon, interventional cardiology, and other specialties depending on patients' presentations, and recognition of the need for joint operators in some critical situations, will ensure appropriate treatment selection, shared decision-making, and optimal outcomes for the patient.

Indications

Updates to covered indications must be driven by comprehensive evidence and professional consensus. Medtronic applauds CMS for taking into consideration both when the agency reconsidered the TAVR NCD in 2019, examining the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease (13) as well as professional consensus documents such as the multi-societal Expert Consensus Systems of Care document (8) which was commissioned by the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS) to summarize their collective positions on the availability, delivery, organization, and quality of cardiovascular care.

Patient access and advancement in indications dually benefit from trials that are rigorous and representative in their design and execution. Previously approved TAVR indication expansions have occurred across multiple trials, populations, and devices. The rigor of these trials has driven clinical confidence and consensus on the benefits of TAVR in the studied populations. Medtronic believes that further trial experience, professional consensus, intentional recruitment of underserved populations, and ongoing evidence development is necessary to confirm the results of TAVR for asymptomatic AS and establish with greater rigor and confidence the benefits in the expansion population.

In patients with symptomatic aortic stenosis (AS) and normal tricuspid valve morphology, the evidence base robustly supports TAVR under the current coverage criteria. Randomized controlled trials (RCTs) have compared TAVR with surgical SAVR across the full spectrum of surgical risk, predominantly in elderly populations with tricuspid AS. Among patients deemed unsuitable for surgery, early landmark trials demonstrated the superiority of TAVR over medical therapy. (14) We further note, and describe below in more detail, that access to this therapy in the US has grown within the context of Medicare’s program requirements and, accordingly, that the evidence that has been generated in the US, notably for this population, highlights the success of hospitals that meet those Medicare requirements. Such evidence for these symptomatic AS populations has yet to be developed in a robust manner outside the infrastructure, institutional, physician, care team, and data reporting requirements Medicare currently requires for TAVR in the Medicare population.

While evidence is emerging on TAVR as a treatment option for the asymptomatic aortic stenosis population, we caution that long-term outcomes will be important to establish and monitor for these patients. In the symptomatic population, RCTs subsequent to the early landmark study established the non-inferiority of TAVR relative to SAVR in patients at high (15, 16, 17), intermediate (18, 19, 20), and low surgical risk (21, 22, 23, 24). But importantly, comparable longer-term outcomes have been reported during follow-up periods extending from five to ten years. Similarly, meta-analyses of RCT data indicate a reduction in all-cause mortality and disabling stroke with TAVR compared with SAVR at one year in low-risk patients, and importantly, with no significant differences observed at longer-term follow-up or among patients at intermediate or high surgical risk (25, 26). These long-term data are not yet available for the asymptomatic population.

The ability to diagnose asymptomatic AS and existing clinical guidelines are not yet mature enough for CMS to use for coverage without additional evidence development. It has been observed that 40% of patients with severe AS are asymptomatic at the time of diagnosis (27, 28). In approximately one-third of such patients, exercise testing reveals symptoms or impaired exercise capacity attributable to AS (29, 30, 31); the remaining patients are deemed truly asymptomatic. Existing guidelines recommend clinical surveillance for asymptomatic AS and preserved left ventricular ejection fraction and are scheduled to be updated later this year. Specifically, the 2020 ACC/AHA Guidelines recommend a strategy of watchful waiting with close surveillance—typically echocardiographic follow-up every 6 to 12 months—for asymptomatic patients with severe AS and preserved left ventricular ejection fraction (LVEF), deferring intervention until symptom onset or a decline in LVEF below 50%. The guidelines also provide Class IIa/IIb recommendations for early intervention in selected scenarios, including markedly elevated BNP levels (>3× normal), exercise-induced hypotension, very high transvalvular velocities (Vmax >5 m/s), or progressive decline in LVEF, even in the absence of classical symptoms, particularly in patients at low surgical risk. These decisions are emphasized to occur within the context of a multidisciplinary heart valve team (32). The next ACC/AHA guideline update is not anticipated until the fourth quarter of 2026 or first quarter of 2027, according to the official publication schedules. (33) In the interim, it may be prudent to await these comprehensive literature reviews and expert consensus updates before finalizing any decision to include asymptomatic patients, particularly given the limited volume and duration of RCT data in this population.

Similarly, while promising, the evidence of efficacy of TAVR in asymptomatic patients is focused on one trial plus another which is noted to have inadequate statistical power, with two more RCTs currently enrolling. The robustness and long-term nature of these trials pale in comparison with the analyses that have been done using the TVT-R data for the symptomatic AS population. Medtronic believes that as they stand, these data points do not sufficiently answer the questions posed by Medicare with respect to CED of TAVR, if only because they are limited to clinical trial cohorts.

• The EARLY TAVR trial randomized 901 asymptomatic patients with preserved ejection fraction to early TAVR or clinical surveillance and reported a 50% relative reduction in the primary composite endpoint of all-cause mortality, stroke, or unplanned cardiovascular hospitalization with early intervention. However, this result was largely driven by the 26.2% of patients in the surveillance group who underwent TAVR within six months due to symptom development or emerging adverse prognostic features. Importantly, no significant differences were observed in all-cause mortality or stroke during five-year follow-up (34. 35).
• The EVoLVeD trial enrolled 224 asymptomatic patients with severe AS and evidence of myocardial fibrosis on cardiac magnetic resonance imaging. Early valve intervention (SAVR or TAVR) did not reduce the incidence of all-cause death or unplanned AS-related hospitalization compared with clinical surveillance. Interpretation of these findings is limited by inadequate statistical power and a median delay of five months to intervention in the experimental arm (36).
• Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study (EASY-AS) (NCT04204915) and Danish National Randomized Study on Early Aortic Valve Replacement in Patients With Asymptomatic Severe Aortic Stenosis (DANAVR) (NCT03972644) are ongoing RCTs that are currently recruiting and will further inform and refine the management of patients with severe asymptomatic AS.

Given the emerging status of evidence in the asymptomatic AS population, Medtronic believes careful CMS review of the clinical results is warranted, with a specific focus on open questions that must be addressed to provide further clarification on the long-term results of TAVR therapy in this population.

Hospital and Physician Experience Requirements

Medicare’s institutional, physician, and infrastructure requirements for TAVR programs serve – and should continue to serve – as the foundation for high quality care, not only for TAVR therapy, but across the landscape of newly introduced transcatheter structural heart therapies. Changing these requirements prematurely could place all patients with valve disease at risk. Medicare has a vital role in partnership with clinicians to ensure best practices continue as patient access grows.

Medicare should rely first and foremost on professional consensus and evidence for considering changes to TAVR program requirements and ensure that any changes are carefully assessed through continued requirements for evidence development. We note that updates to these will be available and the end of 2026 or beginning of 2027. Furthermore, any potential changes need to take into consideration the impact on the quality of care provided across the transcatheter structural heart space.

The STS/ACC TVT Registry National Slide Set 2015-2024 from July 2025 shows that TAVR sites have increased from 400 in 2015 to 659 in 2019 and then to 850 in 2024, and that utilization of TAVR has correspondingly increased from 25,647 in 2015 to 73,396 in 2019 to 106,107 in 2024.(37) As the number of patients with AS receiving TAVR continues to increase, it remains critical for CMS to continue recognizing the complexity of inpatient care needed by this patient population and the significant post-procedural care needed before a Medicare beneficiary can be discharged from the hospital.

Clinical literature consistently finds an association between higher institutional TAVR procedure volume and better patient outcomes compared with lower-volume centers, including the work cited in CMS’s 2019 TAVR NCD reconsideration. This relationship has been examined in observational cohorts, registry analyses, and systematic reviews/meta-analyses in multiple healthcare systems:

• A meta-analysis summarizing evidence up to 2020 concludes that, for high surgical risk patients, a significant volume-outcome relationship exists post-TAVR in both the highest and intermediate volume hospitals compared with the lowest volume hospitals while noting that this relationship requires further study for low-risk patients. (38)
• Another meta-analysis in 2021 showed an inverse relationship between volume and all-cause mortality, with a relative reduction in mortality rates of 37%, 23% and 19%, for high volume versus low volume centers, high volume versus intermediate volume centers and intermediate versus low volume centers, respectively. This is noteworthy because across all seven of the studies included in this meta-analysis, the results showed that the higher volume centers in the study had a lower all-cause mortality rate compared to lower volume centers. The authors of this meta-analysis concluded the need to focus on development of strong referral networks and consolidation rather than expansion of existing TAVR centers to improve patient outcomes, while ensuring adequate access-to-care. (39)
• An analysis of all-payer inpatient data on US TAVR from 2019 corroborates this finding. This data analysis of US TAVR programs showed that in-hospital mortality after total AVR (SAVR or TAVR) is inversely related to hospital total volumes of AVR. The authors conclude that patients with aortic stenosis have better outcomes if they are managed among experienced centers with high case volumes of both TAVR and SAVR. (40)
• A separate analysis of US TAVR all-payer inpatient data from 2016 through 2019 also demonstrates an inverse volume-mortality relationship, showing significantly higher mortality and 30-day post-TAVR readmission rates at low volume hospitals compared with high volume hospitals. (41)
• TAVR programs with higher procedure volumes also are associated with better outcomes with emergency TAVR, according to an analysis in 2021 of the US utilization from 2014 to 2017 (42) and an analysis in 2022 of utilization in Germany from 2018. (43) This is notable because emergency TAVR has been shown to be associated with worse in-hospital complications and higher mortality rates compared with elective TAVRs.
• Yet another meta-analysis found that this inverse relationship between volume and mortality pertained not only to TAVR, but also SAVR, driving at the importance of center level volume requirements for patients regardless of what type of AVR therapy they require. This meta-analysis showed an inverse relationship between procedure volume and short-term mortality also exists with regard to SAVR, finding that patients from the lowest-volume hospital were more likely to die, develop major complications, and experience failure-to-rescue events. (44)

This association appears to hold for the procedural volume requirements for operators. While noting a similar relationship between TAVR procedure volume and clinical outcomes as the other meta-analyses above, a study in 2021also pointed to an inverse relationship between procedural volumes and the clinical outcomes at the operator level. Specifically, the study found that the occurrence of adverse events decreased after the first 128 cases for each operator in joint operator TAVR cases. It additionally found that mortality and major cardiac events increase as operator volumes for percutaneous coronary interventions (PCI) decrease. (45) A study published in January 2026 found that an inverse relationship between volume and quality existed even with the most recent data from 2020-2023, finding that low volume TAVR and MTEER operators demonstrated inferior results on process of care measures relative to high volume operators. Importantly, on mortality and in-hospital complications, higher risks for both were observed for low-volume TAVR operators compared to higher volume operators. (46)

As the evidence and field develop and grow, there is discussion of potential alternatives to volume requirements that could be tested or explored. For example:

• In 2023, one study modeled the association of volume compared to composite outcome thresholds in the US. By assigning patients to and from different TAVR programs, they were able to model outcomes and concluded that a simulated volume threshold might not necessarily result in the best outcomes for all populations and that a referral to a TAVR program based on outcome might result in better outcomes albeit with more driving time. (47)
• The 2019 AATS/ACC/ASE/SCAI/STS Expert Consensus Systems of Care Document includes a tiered approach to treating valve disease, drawing on experience and evidence with other organized and tiered systems of care for acute problems (stroke, trauma, and myocardial infarction) and selected chronic disorders (bariatric surgery for obesity, adult congenital disease, pulmonary hypertension). At that time, they provided guidance on Primary and Comprehensive Valve Centers, where Primary Centers perform fundamental valve procedures, including SAVR, surgical mitral valve replacement and repair, and transfemoral TAVR, while Comprehensive Centers offer additional procedures, such as alternative access TAVR, TEER, valve-in-valve procedures, and complex open valvular surgery. This framework could continue to expand or be refined to account for experience and evidence with new indications, populations, and centers. (48)

Taken together, extensive analyses of real-world evidence clearly show that TAVR centers with higher institutional TAVR procedure volume have better patient outcomes compared with lower-volume centers, and that a learning curve exists with regard to procedural efficiency. Not only do these findings exist at the institutional level, studies have also shown that these patterns seem to exist at the operator level. TAVR patients are more likely to have better outcomes when their TAVR operators perform more procedures, and they appear to decline when TAVR operators decrease the number of PCIs they perform. It stands to reason that, based on this large body of research, CMS should continue to maintain some level of institutional and procedural volume requirements to support positive patient outcomes for TAVR.

An additional consideration is that these requirements not only provide a fertile environment to cultivate positive patient outcomes for TAVR, but they also provide a foundation for Medicare coverage of novel new structural heart therapies such as transcatheter tricuspid valve replacement (TTVR) and transcatheter tricuspid edge-to-edge repair (T-TEER), both of which are typically provided in hospitals that perform TAVR procedures. In fact, Medtronic analysis of Medicare data shows that 100% of Medicare’s TTVR procedures performed in FY2023 were performed in TAVR centers. (4) The recently established NCDs for T-TEER and TTVR have been far less prescriptive on institutional and operator requirements than the existing TAVR NCD, instead relying on physician criteria that simply require patients to be under the care of heart teams consisting of cardiac surgeons, interventional cardiologists, and other specialists as necessary. While the multidisciplinary heart team approach was first established in the TAVR NCD, it has been augmented in the TAVR NCD by hospital infrastructure requirements and specific physician and hospital procedural volume requirements to ensure high quality health outcomes for patients with AS. The institutional framework of the TAVR NCD serves as the cornerstone of other structural heart NCDs. A study for 2023 analyzing US all-payer inpatient data from 2016 to 2018 found that, despite specific procedural differences between TAVR and TEER, the lowest volume TAVR centers are associated with increased morbidity and mortality after TEER. The authors conclude that this might be due to advantages in infrastructure, resources, and expertise present in higher volume transcatheter intervention centers. Because the requirements in the TAVR NCD promote high quality care for TAVR patients while also providing an underlying foundation for the provision of high-quality care to T-TEER and TTVR patients, any changes to these requirements in the TAVR NCD must carefully consider the impact across the transcatheter structural heart space. (49)

In summary, some level of proficiency (i.e., volume) with aortic valve replacements combined with the presence of on-site heart valve surgery and interventional cardiology programs and post-procedural care facilities is critical to driving optimal patient outcomes. All of the higher volume facilities described in the findings above in the US have this combination. The studies looking at the relationship between SAVR volumes and TAVR outcomes reinforce this point. An editorial in response in 2020 asserts that proliferation of TAVR is leading to less hesitation around its use, and, accordingly, multidisciplinary heart teams and experienced surgeons are needed to recognize and manage high-risk features (e.g., low-lying coronary arteries, heavy calcification of the left ventricular outflow track): “The wrong procedure in the correct patient or the correct procedure in the wrong patient are both more likely to lead to less optimal outcomes.” (50) Revisions to the TAVR NCD’s institutional and physician requirements, if any, must continue to ensure programs have the appropriate level of experience for optimal patient outcomes and procedural efficiency as well as on-site capacity for addressing complexities that may arise during TAVR procedures. Medicare should continue to rely on the most up to date professional consensus and evidence-based guidelines for coverage policy, and since updates for TAVR are expected at the end of 2026 or beginning of 2027, consider delaying this reconsideration until those updates are available.

Evidence Development and the TAVR Registry

The STS/ACC TVT Registry (TVT-R) has been an essential mechanism to collect evidence and expand the knowledge base on TAVR therapies in the context of CMS’ coverage to date. Given uncertainty about key questions on both expanded indications and potential changes in hospital/physician/heart team program requirements, conclusions regarding whether coverage policy changes in these areas are fully warranted cannot be made. In such instances, CED would remain appropriate. Medtronic believes the TAVR registry should remain in place to address uncertainties posed by potential revisions to the NCD. Building the evidence on TAVR patient outcomes over time has been critical to determining the degree to which TAVR is reasonable and necessary for the treatment of symptomatic AS. Healthcare professionals, societies, researchers, and device-manufacturers have benefited from the consistent participation and monitoring of TAVR outcomes through the TVT-R.

Since 2011, data from TVT-R has showcased results in a “real-world” population as opposed to the populations identified in clinical trial cohorts. For example, the STS/ACC TVT Registry National Slide Set, 2015-2024 from July 2025 shows utilization trends from 852 TAVR sites in the US and provides meaningful descriptive TAVR patient statistics and frequencies of major complications from TAVR. (37) We note that, importantly, the use of real world data such as that from TVT-R is directly aligned with HHS’ broader priorities outside the specific context of TAVR, as reflected in FDA’s December 2025 guidance that would enable it to more broadly incorporate real-world evidence (RWE) in some medical device approvals, removing as a requirement that the data submitted from real-world data sources be individually identifiable patient information. (51) Additionally, in 2024, in finalizing its Transitional Coverage for Emerging Technologies (TCET) coverage pathway, CMS explicitly discussed the allowance of both traditional clinical study designs and/or fit-for-purpose study designs, including those that rely on secondary use of real-world data, in Evidence Development Plans. (52) In alignment with the most recent FDA guidance on RWE supporting regulatory decisions in medical devices and CMS’ technical guidance around RWE in the context of CED, the TVT registry is a well-established, fit-for-purpose, and robust source for continued evidence generation.

As CMS reconsiders the covered patient indications for TAVR and the physician and hospital requirements for the provision of TAVR procedures, any potential changes to the existing coverage policy will introduce a variety of new questions about the impact of the coverage revisions, including long-term evidence on the benefit of TAVR to asymptomatic patients and the quality of outcomes in new facilities if physician/operator/institutional requirements are revised. CED remains an appropriate mechanism to address these questions for TAVR.

In general, Medtronic believes the existing evidence-based on TAVR is well developed to demonstrate improvements in net health outcomes in the Medicare population, and that the technology is reasonable and necessary for the treatment of symptomatic AS, particularly severe symptomatic AS. At the same time, we observe that the current TVT-R data may not provide full information on the long-term outcomes and adverse events for the newest generation of TAVR platforms as the field for structural heart therapy continues to grow and evolve (including recent authorizations of new products and additional ones being evaluated in IDE studies for new indications or initial market entry, which may not be supported by RCTs).

Equally as strongly, Medtronic believes that CMS needs to address evidence development for populations where only one or two clinical trials have concluded. It would be hasty for CMS to bypass evidence development in considering coverage of indications with only results from one adequately powered clinical trial rather than a wealth of real-world evidence – particularly when such robust infrastructure already exists. Specifically, we note that the National Coverage Analysis (NCA) considers the expansion of access to TAVR for populations that have thus far been studied on a limited basis under specific protocols. Furthermore, the NCA contemplates the possibility that TAVR implant procedures could be performed at institutions and by care teams that may not meet the existing requirements for coverage as specified by Medicare. CED is necessary most especially in the context of these two possibilities so that the research questions addressed by the TVT-R can be answered in the context of new populations and new care providers/operators.

Overall, Medtronic supports the use of CED as a mechanism to support coverage and evidence generation. Continuation of CED via the registry ensures TAVR outcomes in the Medicare population can continue to be captured in a minimally burdensome manner, benefiting TAVR patients, providers, and continued innovation – the critical importance of which only increases as expanded patient populations and changes in how, where, and by whom TAVR procedures are performed are being contemplated, whether through this NCD reconsideration or in the future.

Conclusion

Thank you again for the opportunity to comment on the second reconsideration of the Medicare national coverage analysis for Transcatheter Aortic Valve Replacement (CAG-00430R2). We appreciate CMS’ consideration of these comments. If you have questions or need further information, please contact me at jeff.a.farkas@medtronic.com.

Sincerely,

Jeff Farkas
Vice President, Health Economics, Policy, and Reimbursement
SH&A, PVH, CRDN, CS
Medtronic

References
1. Medicare Decision Memo on TAVR, 2012. CAG-00430N. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=257
2. Medicare Decision Memo on TAVR, 2019. CAG-00430R. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=293&bc=ACAAAAAAQAAA&
3. Medicare National Coverage Analysis Tracking Sheet on TAVR, 2025. CAG-00430R2. https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=321&NCDId=355&ncdver=2&TAId=6&MEDCACId=6&CALId=150&SearchType=Advanced&CoverageSelection=National&NCSelection=NCA%7CCAL%7CNCD%7CMEDCAC%7CTA%7CMCD&KeyWord=CLINICAL%2BTRIAL&KeyWordLookUp=Doc&KeyWordSearchType=Exact&kq=true&IsPopup=y
4. Pedroso AF, Vora A, Dhingra LS, Aminorroaya A, Khera R. Evaluating the Accessibility of Transcatheter and Surgical Aortic Valve Replacement Across the US Via Driving-Times. Am J Cardiol. 2025 Dec 29:S0002-9149(25)00743-X. doi: 10.1016/j.amjcard.2025.12.007. Epub ahead of print. PMID: 41475454.
5. David G, Epstein AJ, Giri J, Nathan A, Chikermane SG, Ryan M, Thompson C, Clancy S, Gunnarsson C. No-Transcatheter Aortic Valve Replacement (TAVR) Zones and Their Effect on Access to Care for Medicare Beneficiaries with Aortic Stenosis. Adv Ther. 2025 Apr;42(4):1716-1728. doi: 10.1007/s12325-025-03116-8. Epub 2025 Feb 13. PMID: 39945944; PMCID: PMC11929678.
6. Castaldi G, Matetic A, Bagur R, Abbott JD, Alasnag M, Chieffo A, Wijeysundera HC, Mamas MA. Sex-Associated Disparities in Surgical and Percutaneous Management of Aortic Stenosis With Severe Features: Retrospective Analysis From the National Readmission Database. J Am Heart Assoc. 2025 May 20;14(10):e038463. doi: 10.1161/JAHA.124.038463. Epub 2025 May 15. PMID: 40371608; PMCID: PMC12184593. https://pubmed.ncbi.nlm.nih.gov/40371608/
7. Spitzer, Ernest. Costa, Francesco. Guðmundsdóttir, Ingibjörg Jóna. de la Torre Hernández, José M. Testa, Luca. McFadden, Eugene. Hanet, Claude. Daemen, Joost. Van Belle, Eric. Iglesias, Juan F. Allocco, Dominic. Dietzsch, Sonja. Jönsson, Anders. Slots, Tristan. Negoita, Manuela. Hutson, Chananit S. Larrubia-Valle, Jose I. Paredes, Ximena S. Erlinge, David Kandzari, David E. Ren, Claire B. de Prado, Armando Pérez Boersma, Eric. Pibarot, Philippe. Tijssen, Jan G.P. Banning, Adrian P. Cutlip, Donald E. Delgado, Victoria, Krucoff, Mitchell W. Underrepresented patient populations in cardiovascular device trials: A transatlantic expert narrative on sex, age, demographic groups, and geographical background. 2026 Jan 15; 443. 133930. International Journal of Cardiology. https://doi.org/10.1016/j.ijcard.2025.133930
8. Bavaria JE, Tommaso CL, Brindis RG, Carroll JD, et al. 2018 AATS/ACC/SCAI/STS Expert consensus systems of care document: Operator and institutional recommendations and requirements for transcatheter aortic valve replacement: A joint report of the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2018 Jul 18. pii: S0735-1097(18)35377-4.
9. Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17. Erratum in: Circulation. 2021 Feb 2;143(5):e228. doi: 10.1161/CIR.0000000000000960. Erratum in: Circulation. 2021 Mar 9;143(10):e784. doi: 10.1161/CIR.0000000000000966. PMID: 33332149.
10. Makkar R. Editorial on the 2021 ISMICS Expert Consensus Statement on TAVR/SAVR. Innovations (Phila). 2021 Jan-Feb;16(1):24-25. doi: 10.1177/1556984521991908. PMID: 33645302.
11. Hirji SA, McCarthy E, Kim D, McGurk S, Ejiofor J, Ramirez-Del Val F, Kolkailah AA, Rosner B, Shook D, Nyman C, Berry N, Sobieszczyk P, Pelletier M, Shah P, O'Gara P, Kaneko T. Relationship Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes. JACC Cardiovasc Interv. 2020 Feb 10;13(3):335-343. doi: 10.1016/j.jcin.2019.09.048. PMID: 32029250; PMCID: PMC8858441
12. Gandjian M, Verma A, Tran Z, Sanaiha Y, Downey P, Shemin RJ, Benharash P. Influence of center surgical aortic valve volume on outcomes of transcatheter aortic valve replacement. JTCVS Open. 2022 May 30;11:62-71. doi: 10.1016/j.xjon.2022.05.010. PMID: 36172405; PMCID: PMC9510825.
13. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135:e1159–e1195.
14. Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597–607. https://doi.org/10.1056/NEJMoa1008232.
15. Gleason TG, Reardon MJ, Popma JJ, Deeb GM, Yakubov SJ, Lee JS, et al. 5-Year outcomes of self-expanding transcatheter versus surgical aortic valve replacement in highrisk patients. J Am Coll Cardiol 2018;72:2687–96. https://doi.org/10.1016/j.jacc.2018.08. 2146
16. Mack MJ, Leon MB, Smith CR, Miller DC, Moses JW, Tuzcu EM, et al. 5-Year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial. Lancet 2015;385:2477–84. https://doi.org/10.1016/S0140-6736(15)60308-7
17. Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364: 2187–98. https://doi.org/10.1056/NEJMoa1103510
18. Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, et al. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients. N Engl J Med 2016; 374:1609–20. https://doi.org/10.1056/NEJMoa1514616
19. Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med 2017;376:1321–31. https://doi.org/10.1056/NEJMoa1700456
20. Toff WD, Hildick-Smith D, Kovac J, Mullen MJ, Wendler O, Mansouri A, et al. Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis: a randomized clinical trial. JAMA 2022;327: 1875–87. https://doi.org/10.1001/jama.2022.5776
21. Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O’Hair D, et al. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med 2019;380:1706–15. https://doi.org/10.1056/NEJMoa1816885
22. Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, et al. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med 2019;380:1695–705. https://doi.org/10.1056/NEJMoa1814052
23. Blankenberg S, Seiffert M, Vonthein R, Baumgartner H, Bleiziffer S, Borger MA, et al. Transcatheter or surgical treatment of aortic-valve stenosis. N Engl J Med 2024;390: 1572–83. https://doi.org/10.1056/NEJMoa2400685
24. Thyregod HG, Steinbrüchel DA, Ihlemann N, Nissen H, Kjeldsen BJ, Petursson P, et al. Transcatheter versus surgical aortic valve replacement in patients with severe aortic valve stenosis: 1-year results from the all-comers NOTION randomized clinical trial. J Am Coll Cardiol. 2015;65(20):2184-94. doi: 10.1016/j.jacc.2015.03.014
25. Ahmad Y, Howard JP, Arnold AD, Madhavan MV, Cook CM, Alu M, et al. Transcatheter versus surgical aortic valve replacement in lower-risk and higher-risk patients: a meta-analysis of randomized trials. Eur Heart J 2023;44:836–52. https://doi.org/10.1093/eurheartj/ehac642
26. Barili F, Brophy JM, Ronco D, Myers PO, Uva MS, Almeida RMS, et al. Risk of bias in randomized clinical trials comparing transcatheter and surgical aortic valve replacement: a systematic review and meta-analysis. JAMA Netw Open 2023;6:e2249321. https://doi.org/10.1001/jamanetworkopen.2022.49321
27. Pellikka PA, Sarano ME, Nishimura RA, Malouf JF, Bailey KR, Scott CG, et al. Outcome of 622 adults with asymptomatic, hemodynamically significant aortic stenosis during prolonged follow-up. Circulation 2005;111:3290–5. https://doi.org/10.1161/ circulationaha.104.495903
28. Heuvelman HJ, van Geldorp MW, Kappetein AP, Geleijnse ML, Galema TW, Bogers AJ, et al. Clinical course of patients diagnosed with severe aortic stenosis in the Rotterdam area: insights from the AVARIJN study. Neth Heart J 2012;20:487–93. https://doi.org/ 10.1007/s12471-012-0309-3
29. Das P, Rimington H, Chambers J. Exercise testing to stratify risk in aortic stenosis. Eur Heart J 2005;26:1309–13. https://doi.org/10.1093/eurheartj/ehi250
30. Redfors B, Pibarot P, Gillam LD, Burkhoff D, Bax JJ, Lindman BR, et al. Stress testing in asymptomatic aortic stenosis. Circulation 2017;135:1956–76. https://doi.org/10.1161/ CIRCULATIONAHA.116.025457
31. Rafique AM, Biner S, Ray I, Forrester JS, Tolstrup K, Siegel RJ. Meta-analysis of prognostic value of stress testing in patients with asymptomatic severe aortic stenosis. Am J Cardiol 2009;104:972–7. https://doi.org/10.1016/j.amjcard.2009.05.044
32. Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17. Erratum in: Circulation. 2021 Feb 2;143(5):e228. doi: 10.1161/CIR.0000000000000960. Erratum in: Circulation. 2021 Mar 9;143(10):e784. doi: 10.1161/CIR.0000000000000966. PMID: 33332149.
33. https://professional.heart.org/en/guidelines-and-statements/guideline-publication-schedule and https://www.acc.org/guidelines/guidelines-and-clinical-documents-in-progress
34. Généreux P, Schwartz A, Oldemeyer JB, Pibarot P, Cohen DJ, Blanke P, et al. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med 2024;392:217–27. https://doi.org/10.1056/NEJMoa2405880
35. Généreux P, Schwartz A, Oldemeyer JB, Pibarot P, Cohen DJ, Blanke P, Lindman BR, Babaliaros V, Fearon WF, Daniels DV, Chhatriwalla AK, Kavinsky C, Gada H, Shah P, Szerlip M, Dahle T, Goel K, O'Neill W, Sheth T, Davidson CJ, Makkar RR, Prince H, Zhao Y, Hahn RT, Leipsic J, Redfors B, Pocock SJ, Mack M, Leon MB; EARLY TAVR Trial Investigators. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2025 Jan 16;392(3):217-227. doi: 10.1056/NEJMoa2405880. Epub 2024 Oct 28. PMID: 39466903.
36. Loganath K, Craig NJ, Everett RJ, Bing R, Tsampasian V, Molek P, et al. Early intervention in patients with asymptomatic severe aortic stenosis and myocardial fibrosis: the EVOLVED randomized clinical trial. JAMA 2024;333:213–21. https://doi.org/10.1001/ jama.2024.
37. STS/ACC TVT Registry National Slide Set 2015-2024. National Cardiovascular Data Registry. STS National Database
38. Ando T, Villablanca PA, Takagi H, Briasoulis A. Meta-Analysis of Hospital-Volume Relationship in Transcatheter Aortic Valve Implantation. Heart Lung Circ. 2020 Jul;29(7):e147-e156. doi: 10.1016/j.hlc.2019.10.016. Epub 2019 Dec 9. PMID: 32089491
39. Kir D, Shapero K, Chatterjee S, Grimshaw A, Oddleifson A, Spatz ES, Goldsweig AM, Desai NR. Effect of institutional transcatheter aortic valve replacement volume on mortality: A systematic review and meta-analysis. Catheter Cardiovasc Interv. 2021 Sep;98(3):E453-E461. doi: 10.1002/ccd.29502. Epub 2021 Feb 10. PMID: 33565695
40. Elbadawi A, Mohamed A, Sedhom R, Garcia L, Pandey A, Girotra S, Bavry A, Vemulapalli S, Kumbhani DJ. Clinical Outcomes in Relation to Total Hospital Surgical and Transcatheter Aortic Valve Replacement Volumes. J Am Heart Assoc. 2024 Oct;13(19):e035719. doi: 10.1161/JAHA.124.035719. Epub 2024 Sep 18. PMID: 39291503; PMCID: PMC11681448
54. Altibi AM, Ghanem F, Chadderdon S, Lantz G, Song HK, Cigarroa J, Zahr FE, Golwala H. Hospital Procedural Volume and Clinical Outcomes of Transcatheter Aortic Valve Replacement: United States Nationwide Readmission Database, 2016-2019. J Soc Cardiovasc Angiogr Interv. 2022 Oct 17;1(6):100457. doi: 10.1016/j.jscai.2022.100457. PMID: 39132352; PMCID: PMC11308815.
42. Bansal A, Kumar A, Jain V, Reed G, Puri R, Kalra A, Krishnaswamy A, Harb SC, Kapadia SR. Impact of Hospital Procedural Volume on Use and Outcomes of Urgent/Emergent Transcatheter Aortic Valve Replacement. J Am Heart Assoc. 2021 May 4;10(9):e019670. doi: 10.1161/JAHA.120.019670. Epub 2021 Apr 26. PMID: 33899503; PMCID: PMC8200767.
43. Oettinger V, Heidenreich A, Kaier K, Zehender M, Bode C, Duerschmied D, von Zur Mühlen C, Westermann D, Stachon P. Hospital intervention volume affects outcomes of emergency transcatheter aortic valve implantations in Germany. Sci Rep. 2022 Oct 19;12(1):17483. doi: 10.1038/s41598-022-20336-y. PMID: 36261572; PMCID: PMC9581927.
44. He J, Zhang Z, Wang H, Cai L. The Relation between Volume and Outcome of Transcatheter and Surgical Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Cardiovasc Ther. 2020 Apr 18;2020:2601340. doi: 10.1155/2020/2601340. PMID: 32395180; PMCID: PMC7189304.
45. He J, Zhang Z, Wang H, Cai L. The Relation between Volume and Outcome of Transcatheter and Surgical Aortic Valve Replacement: A Systematic Review and Meta-Analysis. Cardiovasc Ther. 2020 Apr 18;2020:2601340. doi: 10.1155/2020/2601340. PMID: 32395180; PMCID: PMC7189304.
46. Kumbhani DJ, Girotra S, Dong H, et al. Contemporary Operator Procedural Volumes and Outcomes for TAVR and MTEER in the US. JAMA Cardiol. Published online January 08, 2026. doi:10.1001/jamacardio.2025.5645
47. Nelson AJ, Wegermann ZK, Gallup D, O'Brien S, Kosinski AS, Thourani VH, Kumbhani DJ, Kirtane A, Allen J, Carroll JD, Shahian DM, Desai ND, Brindis RG, Peterson ED, Cohen DJ, Vemulapalli S. Modeling the Association of Volume vs Composite Outcome Thresholds With Outcomes and Access to Transcatheter Aortic Valve Implantation in the US. JAMA Cardiol. 2023 May 1;8(5):492-502. doi: 10.1001/jamacardio.2023.0477. PMID: 37017940; PMCID: PMC10077135.
48. Nishimura, Rick A. O’Gara, Patrick T. Bavaria, Joseph E. Brindis, Ralph G. Carroll, John D. Kavinsky, Clifford J. Lindman, Brian R. Linderbaum, Jane A. Little, Stephen H. Mack, Michael J. Mauri, Laura. Miranda, William R. Shahian, David M. Sundt, Thoralf M. III. 2019 AATS/ACC/ASE/SCAI/STS Expert Consensus Systems of Care Document: A Proposal to Optimize Care for Patients With Valvular Heart Disease. May 2019.
49. Awtry J, Newell P, Vinholo TF, Harloff M, Kerolos M, Manful A, Dey T, Kaneko T, Sabe A. The Relation Between Hospital Transcatheter Aortic Valve Replacement Volume and Transcatheter Edge-to-Edge Repair Outcomes: A Study Using the National Readmissions Database. Am J Cardiol. 2023 Oct 28:S0002-9149(23)01132-3. doi: 10.1016/j.amjcard.2023.10.006. Epub ahead of print. PMID: 39491846.
50. Mack MJ, Svensson L. Why Does More SAVR Make Better TAVR? JACC Cardiovasc Interv. 2020 Feb 10;13(3):344-345. doi: 10.1016/j.jcin.2019.12.014. PMID: 32029251.
51. 90 Fed. Reg. 59127
52. 89 Fed. Reg. 65724

Less

January 14, 2026

Centers for Medicare and Medicaid Services
Coverage and Analysis Group

Re: Public Comment on Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement, CAG-00430R2

Submitted electronically

Dear Members of the Coverage and Analysis Group:

We appreciate the opportunity to comment on the proposed reconsideration of the National Coverage Decision requiring Coverage with Evidence Development (NCD with CED) for transcatheter aortic valve replacement (TAVR), CAG-00430R2. Given the wealth of data on TAVR and the significant disparities in access to the procedure as well as outcomes for aortic valve stenosis in the United States, we support reconsideration and expanded Medicare coverage for TAVR. The Partnership to Fight Chronic Disease is an internationally recognized organization of patients, providers, community organizations, business and labor groups, and health policy experts committed to raising awareness of the number one cause of death, disability, and rising health care costs: chronic disease. Heart disease is the leading killer in the United States among Medicare beneficiaries. We support interventions to both prevent and treat heart disease to lessen this toll.

Section 1801 of the Social Security Act prohibits federal officers and employees from “exercis[ing] any supervision or control over the practice of medicine or the manner in which medical services are provided”. Yet, for more than 15 years, the CED coverage limitations on TAVR have limited Medicare coverage for TAVR and beneficiary access as a result. Medicare has persisted in imposing coverage restrictions despite data showing how those coverage restrictions limit access and depress health outcomes for people living with aortic stenosis in rural and other medically underserved areas. After 15 years, dozens of clinical trials, and hundreds of thousands of patient records captured in the TAVR registry, this reconsideration is long overdue. While we commend the collection of real-world data to help improve health outcomes and advance our understanding of disease and medical treatments, the desire for more information should not come at the expense of restricting coverage and access to FDA-approved treatments for chronically ill Medicare beneficiaries.

We also urge CMS and the Trump Administration to take on a broader effort to address the use of CED in the Medicare program. During the first Trump Administration, then HHS General Counsel Robert Charrow issued Advisory Opinion 21-03 which labeled CMS’s basis for claiming legal authority for imposing CED “fundamentally inconsistent” with regulatory definitions and deemed such Medicare payment limits “unlawful”.¹ Moreover, once imposed, CED’s linger—lasting more than 11 years on average —all the while limiting Medicare beneficiaries’ coverage and access.²

TAVR is one example of many where imposing CED requirements have caused preventable harm by limiting Medicare coverage. In a particularly egregious and unprecedented assertion of CED authority in April 2022, CMS for the first time ever imposed CED coverage restrictions on an entire class of FDA-approved therapies for the early stages of Alzheimer’s disease. Medicines in the class remain subject to these CED limited coverage restrictions despite their being approved by the FDA and despite strong objections and calls for reconsideration from medical experts,³ patients and caregivers,⁴ and Members of Congress.⁵

We support the efforts to broaden Medicare coverage for TAVR and encourage more be done to examine and remedy the unlawful imposition of CED to limit Medicare coverage in general. Medicare beneficiaries deserve better.

Sincerely,

Candace DeMatteis, JD MPH
Vice President, Policy
Partnership to Fight Chronic Disease

References:
1 Robert Charrow, HHS Office of General Counsel, Advisory Opinion 21-03, Jan. 14, 2021. Available online at https://drive.google.com/file/d/1swctNCEARvrK0Nzr6ja3268gwcsyR0Ff/view.
2 PFCD, Leaving Medicare Beneficiaries in Limbo. Available online at https://www.pfcdalz.org/_files/ugd/b11210_d1405b6948f84a98b70d677f2be4ede4.pdf.
3 American Academy of Neurology, Letter to CMS in support of reconsideration, Feb. 2, 2023. Available online at https://www.aan.com/siteassets/home-page/policy-and-guidelines/advocacy/comment-letters/lecanemab-ncd-reconsideration-request.pdf. American Academy of Neurology, Formal NCD reconsideration request, June 12, 2023. Available online at https://www.aan.com/siteassets/home-page/policy-and-guidelines/advocacy/comment-letters/23-aan-amended-reconsideration-request.pdf.
4 Alzheimer’s Association, Letter to CMS Administrator Chiquita Brooks-LaSure, Dec. 19, 2022. Available online at https://www.alz.org/getmedia/e8e0a723-8500-4169-b209-533ac1bfd557/final-ncd-reconsideration-request.pdf.
5 Letter from US Senators to CMS Administrator Chiquita Brooks-LaSure, Feb. 17, 2023. Available online at https://www.collins.senate.gov/imo/media/doc/senate_alzheimers_letter_to_cms_and_hhs_-_02-17-23.pdf; Letter from US House of Representative Members to CMS Administrator Chiquita Brooks-LaSure, June 16, 2023. Available online at https://lahood.house.gov/_cache/files/6/a/6a2983bf-36ad-4d38-82fb-8e86b3136824/0BE8E393A03AE489A9643C853B186AC9.house-of-reps-cms-alz-follow-up-letter-6.16.23.pdf.

Less

As a Vice President overseeing cardiovascular services at a large health system, I am writing to encourage CMS to modernize the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). The current framework—requiring two separate pre procedure consultations (one cardiac surgeon and one interventional cardiologist) and a mandated two operator procedural model with fixed specialty roles—no longer aligns with contemporary clinical evidence, current indications, or the realities of today’s cardiovascular workforce.

These outdated requirements introduce avoidable delays that directly compromise patient outcomes and increase Medicare expenditures. A substantial body of literature demonstrates that prolonged wait times for TAVR are associated with higher rates of heart failure decompensation, urgent or emergent hospitalizations, and increased pre procedure mortality. These delays also generate significant, preventable costs through repeated admissions and emergency care. At the same time, emergent conversion to open surgery during transfemoral TAVR has become exceedingly rare in experienced programs, with rates typically below 1%.

The existing NCD also fails to reflect current guideline supported indications. TAVR is now established therapy across the full surgical risk spectrum, including low risk patients. Moreover, emerging evidence underscores the importance of early intervention in asymptomatic severe aortic stenosis. The EARLY TAVR randomized trial demonstrated meaningful reductions in death, stroke, and unplanned cardiovascular hospitalization with early TAVR compared with clinical surveillance. Observational studies further show that a significant proportion of “asymptomatic” patients deteriorate before treatment, often requiring urgent admission and experiencing worse outcomes. Updating the NCD to incorporate these contemporary indications is essential to preventing avoidable morbidity, mortality, and cost escalation.

Workforce constraints further heighten the urgency of modernization. National projections indicate a substantial shortage of cardiothoracic surgeons in the coming decade. Requiring CT surgeon involvement in every TAVR evaluation and procedure—regardless of case complexity—diverts limited surgical resources from higher acuity needs and disproportionately impacts rural and underserved communities. A heart team approach is still considered a best practice to evaluate the appropriate patient treatment and management plan, but that can be done without mandating two distinct patient evaluations.

To align federal policy with current evidence, improve access, and reduce unnecessary cost, I respectfully urge CMS to revise the NCD to:

• Allow a single pre procedure consultation from either a cardiac surgeon or an interventional cardiologist, based on patient needs and local program structure.
• Permit hospitals to determine whether one or two operators are appropriate for each case, rather than mandating a fixed two operator model.
• Consider volume thresholds for operators to be able to perform procedures independently.
• Incorporate contemporary indications, including asymptomatic severe aortic stenosis, consistent with current guidelines and the EARLY TAVR trial.

These updates would preserve the collaborative heart team approach while removing outdated barriers that delay care, increase cost, and worsen outcomes. Modernizing the TAVR NCD is essential to ensuring timely, evidence based, and equitable access to this life saving therapy for Medicare beneficiaries.

Less

Dr. Mehmet Oz, Administrator
Centers of Medicare & Medicaid Services
200 Independence Avenue SW, Washington, DC 20201

Dear Dr. Oz and CMS,

We read with interest the letter by Edwards Lifesciences dated July 28, 2025 requesting CMS update the 2019 TAVR NCD to reflect the recent evolution of the TAVR landscape in the United States. After reviewing the document in detail, we would like to endorse the following initial thoughts regarding the care of patients with aortic valve disease:
1) changes to the NCD should be led by professional societies, whose missions’ are to protect public safety and interest, rather than by industry given the potential conflicts of interest in advocating for such changes.
2) as an overwhelming majority (94%) of TAVR patients are Medicare beneficiaries¹, it is therefore paramount for CMS to understand its importance as the decision maker on the TAVR NCD and act as the main advocate in the interest of patient safety.

By way of introduction, our program at Columbia performed the first TAVR in the United States, has led multiple national and international randomized clinical trials in transcatheter valve technology, and has been a strong champion of the value of a heart valve team approach. We believe that this commitment to a multi-disciplinary approach to all valve therapies, both surgical and transcatheter, has directly resulted in the outstanding outcomes that have been achieved in the valve field. Specifically, the contributions of cardiologists, surgeons and imagers have been equally important to our delivery of high-quality care.

We would like to specifically address the proposed NCD changes with the following point-by-point response and recommendations:

Point #1: Updates to the TAVR NCD are needed to include asymptomatic patients not addressed under the current policy

RESPONSE: While we acknowledge that the evidence on the benefit of treatment of asymptomatic severe AS with aortic valve replacement (AVR) has increased since the last NCD, particularly in surgical aortic valve replacement^2-6, continued evaluation of TAVR is necessary to fully determine the short and long-term benefit of the procedure in this patient population. While we agree that TAVR demonstrates short-term readmission benefit in patients with asymptomatic severe AS, longer-term data are warranted to confirm the clinical benefit of TAVR in asymptomatic severe AS before recommending its widespread use. Furthermore, it remains unclear what the long-term impact of earlier intervention will be on lifetime management and subsequent reintervention, particularly when longer term durability data are lacking for TAVR.

Point #2: Cumulative evidence demonstrates that TAVR no longer requires CED and is reasonable and necessary for the benefit category of inpatient hospital services and physician services in the treatment of AS.

RESPONSE: TAVR has become a Class I indication in patients with symptomatic severe AS across all surgical risk patients in the current valve guidelines⁷ based on the large body of randomized trial and real-world registry evidence after FDA approval. Critically, the STS/ACC TVT registry has served as a benchmark on the evaluation and reporting of TAVR safety and quality outcomes across >860 centers in the United States. The TVT registry continues to generate a large body of evidence on TAVR in the US, including the importance of the volume-outcome relationship and outcomes for indications beyond the initial FDA approval, such as valve-in-valve procedures and patients with pure aortic regurgitation.^8-11 The largest body of randomized trial and registry evidence remains only in patients with symptomatic severe AS with trileaflet anatomies. Randomized trials on TAVR vs SAVR in bicuspid anatomies are poised to begin and real-word registry data in this patient population are essential. Furthermore, valve-in-valve procedures, especially redo-TAVR in failed transcatheter aortic valves, are increasing in volume with only limited short- and mid-term data in the United States. Since TAVR with the Edwards Sapien 3 valve has only recently been FDA approved for asymptomatic severe AS, it is even more essential to have real-world data captured via the TVT registry on the safety and quality of TAVR in these newly defined populations in the US. In the future, there will be FDA approved novel TAVR devices for use in pure aortic regurgitation, and further real-world evidence utilizing the TVT registry to track patient safety and outcomes will be critical. We therefore believe that the notion that “TAVR no longer requires CED” fails to recognize the expanding patient population and device therapies that require further evidence generation.

Ongoing TVT registry reporting and continuous development of real-world evidence is paramount to protect public safety and maintain the quality of TAVR performed in the US. The CED is essential for ongoing monitoring of TAVR use presently and in specific expanded patient cohorts such as bicuspid valves, valve-in-valve, redo-TAVR, and aortic regurgitation. Moreover, a non-industry adjudicated registry is essential to obtain unbiased outcomes data in these populations to avoid the significant conflicts that exist with industry funded registries. In fact, an analysis of heart-team assessed low-risk TAVR patients in the STS/TVT registry found a greater divergence of 1-year outcomes than 30-day outcomes compared with pivotal trial data, pointing to opportunities for improvement in longitudinal care after low-risk TAVR in the community.¹²

One of the key elements in the CED that has resulted in the excellent quality outcomes for patients receiving TAVR is the integral role of heart team in guiding the optimal therapy for patients with severe aortic stenosis. In fact, the reduction in complications and mortality, and the continued observed improvement in quality of life across the entire spectrum of care for patients with AS is a direct result of the heart team, irrespective of the use of an intervention.¹³ The joint decision making between an interventional cardiologist, cardiac surgeon, and imager directly leads to improved selection of the appropriate treatment option for our patients, be it TAVR or SAVR. Studies have shown that the implementation of a heart team approach enhances access to care, reinforces individualized management decisions, and improves survival.¹⁴ Furthermore, the heart team leads to better procedural-related outcomes and quality of life across all therapies chosen for patients in need of aortic valve replacement regardless of technique chosen. This is particularly important in recipients of Medicare and Medicaid services including those with complex medical and social histories and complex anatomies where not having a team approach would jeopardize patient safety. Dismantling the heart team in joint decision making and procedures would risk inappropriate use of TAVR in aortic valve patients.

We acknowledge that there are significant limitations to the CED mandated registries that limit its utility, including lack of detailed echocardiographic data, absence of longer-term follow-up, and maintenance cost. We urge CMS to help sites and societies make the registries better by fixing these problems, rather than eliminating it altogether. Developing a national independent registry would take this one step further to being a truly unbiased data source.

In conclusion, we advocate for maintaining the CED to preserve the heart team concept, thereby maintaining patient safety and procedural quality. The opportunity to improve the CED should be undertaken by professional societies in concert with CMS to improve known limitations.

Point #3: Updates to the TAVR NCD are needed to streamline and remove outdated and burdensome requirements that create barriers to patient care.

RESPONSE: The 2019 NCD update was designed to improve patient access to TAVR therapies and was successful at doing so. Current evidence has shown success on increasing the number of TAVR centers from 556 at the end of 2018 prior to the last NCD revision to >860 in the present. A recent 2025 study funded by Edwards Lifesciences demonstrated lower population densities and more rural settings created longer travel distances and barriers to access TAVR.¹⁵ In contrast to this study, the NIH funded study by Marquis-Gravel et al already showed significant TAVR penetration among the US population from 2015 to 2017¹⁶, with an average travel time for patients of 35 minutes, which has been further reduced with the growth of TAVR centers to > 860. Even in major metropolitan areas with a high number of TAVR centers per capita, however, ethnic minorities and those with greater socioeconomic disadvantages have lower rates of TAVR.¹⁷ Therefore, access to TAVR may have less to do with travel time and distances but rather other barriers to care for racial minorities and socioeconomically disadvantaged groups. More efforts should be undertaken to reduce systemic barriers to care in these populations, and increasing the number of TAVR programs will not address this issue. In an interesting analysis, shifting patients from their nearest TAVR site to the best outcome site within their referral region would result in a significant reduction in death and adverse events at a cost of an increase in driving time of only 23 minutes.¹⁸ Thus, offering high quality care in TAVR, rather than easier access to care solely by geography, may be more relevant. Efforts should focus on improving the quality of low-volume programs as this may be a key solution to maintain timely yet quality access to TAVR.

The volume-outcome relationship has been shown to be important for TAVR, with an inverse relationship between procedural volume and mortality.⁸ Furthermore, an analysis of Medicare beneficiaries showed that higher hospital SAVR volumes were associated with improved 30-day and one-year mortality after TAVR.¹⁹ This highlights the importance of maintaining minimum TAVR volumes as well as the importance of a viable surgical program in offering high quality TAVR care. Given there are just over 1000 cardiac surgery centers in the US, further increasing the number of TAVR programs would likely result in a dilution of program TAVR volumes, thus likely resulting in the opposite of the intended goal. “Removing outdated and burdensome requirements that care barriers to patient”, including heart team joint decision making and access to both interventional cardiologists and cardiac surgeons, may in fact worsen outcomes in AS treatment, especially in low volume programs that are geographically isolated and serving ethnic minorities and the socioeconomically disadvantaged. Compromising quality of care is not an acceptable consequence of trying to improve access to TAVR.

Yet, there are multiple ways access to care in TAVR can improved and we will highlight some ideas. The ideal evaluation for a patient is to see both a cardiologist and surgeon to determine TAVR and surgical suitability. This in turn provides a valuable system of checks and balances that removes incentivization of care in either direction, while also increasing quality. There may be certain scenarios in which this requirement could be relaxed; for instance, patients deemed to be of high surgical risk by risk calculators used in clinical trials may not require surgical evaluation, given the superiority of TAVR over SAVR in these patients. Reimbursing a heart team meeting in which patients are discussed in detail after a single evaluation could be another way that dual evaluation of all patients could be avoided. Second, allowing two experienced operators to perform TAVR rather than mandating a surgeon and cardiologist is a reasonable evolution. This takes into account the dynamics that occur in various parts of the country in which surgeons or cardiologists are not always available. Local teams can then decide the specifics distribution of care that fits their program. Nonetheless, it would be potentially dangerous to allow single operator TAVR to be reimbursed and therefore allowed, a practice which has no precedent in our history of TAVR. There is great concern that incentivized, single operators that do not provide care within a heart team construct may fail to enagage in appropriate shared decision-making and may degrade the quality of care.

Thank you for your consideration of these comments. Our primary goal is providing the highest level of care to our patients and working to improve the healthcare system.

Isaac George M.D.
Susheel Kodali M.D.
Rebecca Hahn M.D.
Tamim Nazif M.D.
Luigi Pirelli M.D.

Structural Heart & Valve Center
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, NY

References

1. Coylewright M, Grubb KJ, Arnold SV, Batchelor W, Dhoble A, Horne A, Jr., Leon MB, Thourani V, Nazif TM, Lindman BR, et al. Outcomes of Balloon-Expandable Transcatheter Aortic Valve Replacement in Younger Patients in the Low-Risk Era. JAMA Cardiol. 2025;10:127–135. doi: 10.1001/jamacardio.2024.4237
2. Kang DH, Park SW. Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis. Reply. N Engl J Med. 2020;383:92–93. doi: 10.1056/NEJMc2016167
3. Banovic M, Putnik S, Penicka M, Doros G, Deja MA, Kockova R, Kotrc M, Glaveckaite S, Gasparovic H, Pavlovic N, et al. Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis: The AVATAR Trial. Circulation. 2022;145:648–658. doi: 10.1161/CIRCULATIONAHA.121.057639
4. Genereux P, Schwartz A, Oldemeyer JB, Pibarot P, Cohen DJ, Blanke P, Lindman BR, Babaliaros V, Fearon WF, Daniels DV, et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2025;392:217–227. doi: 10.1056/NEJMoa2405880
5. Banovic M, Putnik S, Da Costa BR, Penicka M, Deja MA, Kotrc M, Kockova R, Glaveckaite S, Gasparovic H, Pavlovic N, et al. Aortic valve replacement vs. conservative treatment in asymptomatic severe aortic stenosis: long-term follow-up of the AVATAR trial. Eur Heart J. 2024;45:4526–4535. doi: 10.1093/eurheartj/ehae585
6. Praz F, Borger MA, Lanz J, Marin-Cuartas M, Abreu A, Adamo M, Ajmone Marsan N, Barili F, Bonaros N, Cosyns B, et al. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2025;46:4635–4736. doi: 10.1093/eurheartj/ehaf194
7. Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP, 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;143:e72–e227. doi: 10.1161/CIR.0000000000000923
8. Vemulapalli S, Carroll JD, Mack MJ, Li Z, Dai D, Kosinski AS, Kumbhani DJ, Ruiz CE, Thourani VH, Hanzel G, et al. Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. N Engl J Med. 2019;380:2541–2550. doi: 10.1056/NEJMsa1901109
9. Makkar RR, Kapadia S, Chakravarty T, Cubeddu RJ, Kaneko T, Mahoney P, Patel D, Gupta A, Cheng W, Kodali S, et al. Outcomes of repeat transcatheter aortic valve replacement with balloon-expandable valves: a registry study. Lancet. 2023;402:1529–1540. doi: 10.1016/S0140-6736(23)01636-7
10. Krishnaswamy A, Abbas AE, Babaliaros VC, Greenbaum AB, Yadav P, Moussa ID, Reed GW, Laham RJ, Morse MA, Rodriguez E, et al. Mid-Term Outcomes of Balloon-Expandable Aortic Valve-in-Valve Replacement in the United States. JACC Cardiovasc Interv. 2025;18:1989–2000. doi: 10.1016/j.jcin.2025.06.039
11. Anwaruddin S, Desai ND, Szeto WY, Hermiller JB, Jr., Sorajja P, Kodali S, Popma JJ, Giri J, Herrmann HC, Tang GHL, et al. Self-Expanding Valve System for Treatment of Native Aortic Regurgitation by Transcatheter Aortic Valve Implantation (from the STS/ACC TVT Registry). Am J Cardiol. 2019;124:781–788. doi: 10.1016/j.amjcard.2019.05.045
12. Vekstein AM, Wegermann ZK, Manandhar P, Mack MJ, Cohen DJ, Hughes GC, Harrison JK, Kaneko T, Kapadia SR, Stathogiannis K, et al. Outcomes of Transcatheter Aortic Valve Replacement in Low-Risk Patients in the United States: A Report From the STS/ACC TVT Registry. Circulation. 2025;151:1134–1146. doi: 10.1161/circulationaha.124.071838
13. Jones DR, Chew DP, Horsfall MJ, Chuang AM, Sinhal AR, Joseph MX, Baker RA, Bennetts JS, Selvanayagam JB, Lehman SJ. Multidisciplinary transcatheter aortic valve replacement heart team programme improves mortality in aortic stenosis. Open heart. 2019;6:e000983. doi: 10.1136/openhrt-2018-000983
14. Arjomandi Rad A, Streukens S, Vainer J, Athanasiou T, Maessen J, Sardari Nia P. The current state of the multidisciplinary heart team approach: a systematic review. Eur J Cardiothorac Surg. 2024;67. doi: 10.1093/ejcts/ezae461
15. David G, Epstein AJ, Giri J, Nathan A, Chikermane SG, Ryan M, Thompson C, Clancy S, Gunnarsson C. No-Transcatheter Aortic Valve Replacement (TAVR) Zones and Their Effect on Access to Care for Medicare Beneficiaries with Aortic Stenosis. Adv Ther. 2025;42:1716–1728. doi: 10.1007/s12325-025-03116-8
16. Marquis-Gravel G, Stebbins A, Kosinski AS, Cox ML, Harrison JK, Hughes GC, Thourani VH, Gleason TG, Kirtane AJ, Carroll JD, et al. Geographic Access to Transcatheter Aortic Valve Replacement Centers in the United States: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. JAMA Cardiol. 2020;5:1006–1010. doi: 10.1001/jamacardio.2020.1725
17. Nathan AS, Yang L, Yang N, Eberly LA, Khatana SAM, Dayoub EJ, Vemulapalli S, Julien H, Cohen DJ, Nallamothu BK, et al. Racial, Ethnic, and Socioeconomic Disparities in Access to Transcatheter Aortic Valve Replacement Within Major Metropolitan Areas. JAMA Cardiol. 2022;7:150–157. doi: 10.1001/jamacardio.2021.4641
18. Nelson AJ, Wegermann ZK, Gallup D, O'Brien S, Kosinski AS, Thourani VH, Kumbhani DJ, Kirtane A, Allen J, Carroll JD, et al. Modeling the Association of Volume vs Composite Outcome Thresholds With Outcomes and Access to Transcatheter Aortic Valve Implantation in the US. JAMA Cardiol. 2023;8:492–502. doi: 10.1001/jamacardio.2023.0477
19. Hirji SA, McCarthy E, Kim D, McGurk S, Ejiofor J, Ramirez-Del Val F, Kolkailah AA, Rosner B, Shook D, Nyman C, et al. Relationship Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes. JACC Cardiovasc Interv. 2020;13:335–343. doi: 10.1016/j.jcin.2019.09.048

Less

Dear CMS Leadership,

On behalf of the University of Pennsylvania Transcatheter Aortic Valve Replacement (TAVR) Program, we write to express strong concern regarding CMS’s consideration of removing the requirement that both a cardiac surgeon and an interventional cardiologist be involved in TAVR procedures.

The Heart Team model is the foundation of safe and effective TAVR. It is not a formality. It is the clinical and safety architecture that allowed TAVR to move from experimental therapy to standard of care. From patient selection through procedural execution and complication management, outcomes depend on the integrated judgment and presence of both specialties.

Cardiac surgeons bring essential expertise that cannot be replaced. They are the foremost experts in aortic root and valve anatomy and bring a unique three-dimensional understanding of annular structure, leaflet pathology, coronary relationships, and surgical bailout options that directly informs safe valve selection and deployment. In addition, surgeons are leaders in large-bore arterial access, complex vascular exposure and closure, and the management of calcified or hostile iliofemoral anatomy. In the United States, cardiac surgeons also maintain strong catheter-based skills and routinely perform wire-based, image-guided, and endovascular procedures as part of contemporary practice.

TAVR carries the risk of catastrophic events including annular rupture, coronary obstruction, valve embolization, and cardiac or vascular perforation — situations that require immediate surgical decision-making and intervention. No protocol, remote consultation, or transfer agreement can substitute for a surgeon who is physically present and fully integrated into the procedural team.

Equally important, appropriate patient selection requires surgical judgment regarding anatomy, procedural feasibility, valve durability, re-intervention risk, and long-term outcomes. Removing the Heart Team requirement risks inappropriate use, fragmented care, and erosion of the safety and quality standards that made TAVR successful.

We respectfully urge CMS to retain the requirement for joint cardiac surgeon and interventional cardiologist participation in both the patient selection and the procedural performance of TAVR as a condition of coverage. This standard remains fundamental to patient safety, quality, and the long-term sustainability of this transformative therapy.

Sincerely,

Nimesh D. Desai MD PhD (Cardiac Surgeon Lead) and Paul N. Fiorilli MD (Interventional Cardiologist Lead)

University of Pennsylvania Transcatheter Aortic Valve Replacement Program

Perelman School of Medicine
University of Pennsylvania

Less

January 14, 2026

Joanna Baldwin
Interim Director, Coverage and Analysis Group (CAG)
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244

RE: Transcatheter Aortic Valve Replacement National Coverage Analysis - CAG-00430R2

Dear Ms. Baldwin,

On behalf of the Cardiovascular Service Line of Baylor Scott and White Health (BSWH), I appreciate the opportunity to provide comments on the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Analysis (NCA). BSWH is the largest not for profit healthcare system in Texas with 51 hospitals providing care in both urban and rural regions of North and Central Texas. We performed the first TAVR procedure in Texas in 2007 and are the largest provider of TAVR in Texas with 7 programs providing TAVR procedures to over 1,000 Medicare beneficiaries annually.

Regarding the reconsideration of the national coverage determination (NCD) for TAVR, first and foremost, we feel strongly that we must preserve the foundational elements that have driven the safety, quality, and evidence-based expansion of TAVR and subsequently all structural heart procedures in the U.S. Those include maintenance of a robust Heart Team requirement [1–7], rejection of a single-operator procedural construct [1,2, 8-13] and continued Coverage with Evidence Development (CED) with mandatory participation in the STS/ACC Transcatheter Valve Therapy (TVT) Registry. [14] Together, these elements protect patient-centered decision-making, sustain quality and safety as indications expand, and ensure continued evidence generation as TAVR is increasingly applied to younger, lower-risk, and more complex patient populations.

We specifically request consideration of our input on 4 specific areas of concern regarding coverage:

1. Coverage for Asymptomatic Aortic Stenosis (AS)
2. Continuation of Coverage with Evidence Development (CED).
3. Maintenance of the Heart Team Approach to Care of Patients with AS
4. Continuation of Hospital Program Volume Criteria and Access to Care Considerations

Coverage for Asymptomatic AS

We support the request for coverage of patients with asymptomatic, severe AS. The EARLY TAVR trial showed benefits for treatment with early TAVR compared with active surveillance. However, the benefit was limited to early rehospitalization primarily for crossover procedures with no mortality benefit demonstrated. This trial has also been criticized for possibly being subject to a “placebo effect”. [15] Furthermore, a second trial of patients with asymptomatic AS, the EVOLVED Trial showed no benefit to early TAVR intervention. [16] Thus, we recommend as a condition of coverage of this indication, a provision of Coverage with Evidence Development (CED) to assure that patient care in Medicare beneficiaries is both safe and effective as well as reasonable and necessary for this indication.

We specifically recommend updating the NCD to include any new FDA-approved indications such as asymptomatic AS and future expansion of indications for conditions like aortic regurgitation and moderate AS. This evergreen coverage could be stated as coverage for “any FDA approved indication of aortic valve disease”

Continuation of Coverage with Evidence Development (CED)

CMS’s decision to cover TAVR under CED with mandatory TVT Registry participation has been a highly successful model of evidence-based coverage policy. [14,17,18] Randomized trials have established the safety and efficacy of TAVR in high-, intermediate-, and low-surgical-risk populations. [19-23] We agree that these original questions addressed under CED have been satisfactorily answered. However, as indication expansion continues, new questions are being raised and critical evidence gaps remain, including asymptomatic severe aortic stenosis, bicuspid aortic valve disease younger patients under 65 years , valve-in-valve strategies ( TAV in SAV, TAV in TAV), multivalvular disease, aortic regurgitation, and moderate aortic stenosis where randomized evidence is still being generated . As TAVR increasingly becomes the first valve intervention in younger and lower-risk patients, lifetime management questions—durability, coronary access, conduction disease progression, redo strategies, and cumulative procedural risk—remain incompletely understood. The TVT Registry is uniquely positioned to capture these outcomes longitudinally at a national scale using standardized definitions. [15,24-30]

The TVT Registry has also enabled benchmarking, quality improvement, device surveillance, and policy-relevant evidence generation across the United States. Decoupling coverage from mandatory registry participation would weaken national quality infrastructure precisely as procedural complexity and patient heterogeneity increase. [17,18] Contrary to some criticisms of the burden of the TVT Registry, CED, in fact, supports responsible access expansion by enabling identification of disparities and continuous quality improvement, with data showing widespread geographic access to TAVR and alignment with cardiac care infrastructure. [31] In summary, while mandatory registry participation has created some burden to clinical sites, the benefits far outweigh the burden and cost. Rather than impede access to care, in our opinion, clinical adoption of innovative technology and procedures for Medicare beneficiaries has actually been accelerated by generation of such a strong evidence base of performance and outcomes.

Maintenance of the Heart Team Approach to Care of Patients with AS

The Heart Team construct is foundational to contemporary cardiovascular care and is explicitly embedded in prior CMS TAVR NCDs, professional society guidelines, and systems-of-care frameworks. [1-13] TAVR and other structural heart interventions require multidisciplinary expertise across patient selection, advanced imaging, procedural planning, intraprocedural execution, complication management, and longitudinal follow-up. Multidisciplinary Heart Team evaluation ensures true shared decision-making and protects patient autonomy by ensuring balanced discussions of transcatheter, surgical, minimally invasive, and medical therapies. [1,2,4-7] Clinical outcomes in structural heart disease are highly dependent on appropriate patient selection and planning, assumptions embedded in contemporary endpoint frameworks such as VARC-3. [17,18] We strongly encourage CMS to retain and reaffirm explicit Heart Team requirements.

There has been a push toward a single operator procedure model by some individuals and entities. In our opinion, a shift toward a single-operator model would dismantle the functional core of the Heart Team and incentivize siloed care models. [4-7] Single-operator pathways restrict patient choice, reduce shared decision-making, and increase discipline-driven bias. Dual-discipline participation improves procedural safety, rescue readiness, and real-time decision-making, particularly in programs without fellows or advanced trainees. CMS-aligned billing and coding frameworks for TAVR historically assume two primary operators of different medical taxonomies (interventional cardiology and cardiothoracic surgery), commonly reported using co-surgeon conventions [10-13]. A single-operator construct would misalign coverage policy, procedural reality, and claims infrastructure while slowing innovation in transcatheter and minimally invasive therapies.

Continuation of Hospital Program Volume Criteria and Access to Care Considerations

Hospital and operator volume requirements are supported by ACC/AHA, STS, AATS, and SCAI consensus documents. [32,33] Registry and observational studies consistently demonstrate that higher institutional and operator volumes are associated with lower mortality, fewer complications, and improved outcomes after TAVR. [34–36] For all hospitals and especially lower-volume hospitals, mandatory participation in the TVT Registry is essential for benchmarking and quality improvement. CMS should maintain volume thresholds aligned with professional society guidance and explicitly link lower-volume participation to registry oversight. Elimination of institutional volume requirements will not solve any access to care issues. Rather than provide better access to low density population regions, any further expansion beyond the 860+ existing TAVR programs will result in worse outcomes and a dilution of TAVR experience. [31,32]

Summary

In summary, we support coverage for patients with asymptomatic, severe AS with CED to assure excellent outcomes in patients with this indication. Furthermore, we recommend the NCD cover patients with “aortic valve disease with an FDA approved indication” to cover other possible future indications including aortic regurgitation and moderate AS. We strongly support continuation of CED as this has facilitated access to innovative care for Medicare beneficiaries and is necessary to assure benefits to patients with asymptomatic AS, as well as other further expanded indications. We also want to stress the importance of maintaining Heart Team care delivery and procedural volume requirements to ensure quality and safety, and caution against further dilution of expertise.

Preserving Heart Team requirements, rejecting single-operator constructs, and maintaining mandatory TVT Registry participation together form a coherent, evidence-based policy framework aligned with CMS’s mission to promote high-quality, patient-centered, and accountable care. Thank you for the opportunity to submit our comments.

Molly Szerlip, MD, FSCAI, FACC
Interventional and Structural Cardiology
Regional Director, Structural Heart
Baylor Scott and White The Heart Hospital Enterprise
Assoc. Medical Director, Education and Research
Baylor Scott and White The Heart Hospital Plano

Angel Caldera, MD
Interventional Cardiology
Structural Heart and Valve Disease
Baylor Scott and White- Round Rock, TX

Yashasvi Chugh, MD
Interventional and Structural Cardiology
Baylor Scott and White The Heart Hospital Dallas

Jose F. Condado, MD, MS, FACC, FSCAI
Interventional Cardiology
Structural Heart and Valve Disease
Baylor Scott and White – Round Rock, TX

Michael DiMaio MD
Chief of Staff
Medical Director Surgical Services, Research and Education
Baylor Scott and White The Heart Hospital

Katherine Harrington, MD
Cardiothoracic Surgery
Medical Director, TAVR
Baylor Scott and White The Heart Hospital Plano

Ellie Huff MSN, RN, FACC
Vice President, CV Service Line Operations
Baylor Scott & White -The Heart Hospital

Wm Todd Gray, DO, FACC
Interventional and Structural Cardiology
Medical Director, Cardiovascular Services
Baylor Scott and White The Heart Hospital Denton

Karan Gupta, MD
Interventional Cardiology
Baylor Scott and White Medical Center – All Saints

Anita Krueger MD, FACS
Cardiothoracic Surgery
Vice Chief, Cardiovascular and Thoracic Surgery
Baylor Scott and White Medical Center – All Saints

Michael Mack, MD

Timothy A. Mixon, MD, FACC, FSCAI
Director Cardiac Catheterization Lab
Baylor Scott and White Medical Center – Temple

Robert L. Smith, MD
Chair Cardiovascular Surgery
Baylor Scott and White The Heart Hospital Enterprise
Asst. Medical Director, Cardiovascular Surgery
Baylor Scott and White Health System

Robert Stoler, MD, FACC, FSCAI
Director Interventional Cardiology- South Region
Baylor Scott and White The Heart Hospital Enterprise
Director Cardiac Catheterization Labs
Co-Chief Division of Cardiology
Baylor Scott and White The Heart Hospital Dallas

Minh Tran, MD
Cardiothoracic Surgery
Baylor Scott and White The Heart Hospital Denton

Mark Valentine
Regional President
Baylor Scott and White The Heart Hospital Enterprise

References
1. Otto CM, Nishimura RA, Bonow RO, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease. Circulation. 2021;143:e72–e227.
2. Vahanian A, Beyersdorf F, Praz F, et al. 2021 ESC/EACTS Guidelines for the Management of Valvular Heart Disease. Eur Heart J. 2022;43:561–632.
3. Lawton JS, Tamis-Holland JE, Bangalore S, et al. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization. Circulation. 2022;145:e18–e114.
4. Holmes DR Jr, Rich JB, Zoghbi WA, Mack MJ. The Heart Team of Cardiovascular Care. J Am Coll Cardiol. 2013;61:903–907.
5. Antonides CF. et al. Approaches to the Role of The Heart Team in Therepeutic Decision Making for Heart Valve Disease. Structural Heart Vol 1. 2017
6. Lauck SB, et al. A path forward for the implementation of shared decision-making in valvular heart disease: global joint recommendations from clinicians, patients and researchers. Health Res Policy Syst. 2025 Oct 16;23:136
7. Burzotta, F et al. Clinical Impact of Heart Team Decisions for Patients with Complex Valvular Heart Disease: A Large, Single Center Experience. JAHA vol 11 no. 11 2022
8. CMS. Decision Memo for Transcatheter Aortic Valve Replacement (CAG-00430R).
9. CMS. National Coverage Determination for TAVR (20.32).
10. CMS Claims Processing Manual, Chapter 12.
11. Society for Cardiovascular Angiography and Interventions. Coding Guidance for TAVR. 2024.
12. Noridian Healthcare Solutions. Modifier 62 Co-Surgeon Billing Guidelines.
13. Novitas Solutions. Modifier 62 Fact Sheet.
14. Carroll JD, et al. The STS-ACC Transcatheter Valve Therapy Registry. J Am Coll Cardiol. 2013;62:1026–1034.
15. Généreux P, et al. Transcatheter Aortic-Valve Replacement For Asymptomatic Severe Aortic Stenosis (EARLY TAVR). N Engl J Med 2025;392:217-227
16. Loganath K, Craig NJ, Everett RJ, et al., for the EVOLVED Investigators. Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis: The EVOLVED Randomized Clinical Trial. JAMA 2024;Oct 28:[Epub ahead of print].
17. Généreux P, et al. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021;77:2717–2746.
18. Holmes DR Jr, et al. Annual Outcomes With Transcatheter Valve Therapy. J Am Coll Cardiol. 2015;66:2813–2823.
19. Smith CR, et al. Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients. N Engl J Med. 2011;364:2187–2198.
20. Leon MB, et al. Transcatheter or Surgical Aortic Valve Replacement in Intermediate - Risk Patients. N Engl J Med. 2016;374:1609–1620.
21. Mack MJ, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients (PARTNER 3). N Engl J Med. 2019;380:1695–1705.
22. Popma JJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019;380:1706–1715.
23. Forrest JK, et al. Five-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low Risk Patients with Aortic Stenosis. J Am Coll Cardiol. 2025 Apr 22; 85 (15) : 1523-1532
24. Makkar RR, et al. Association Between Transcatheter Aortic Valve Replacement for Bicuspid vs Tricuspid Aortic Stenosis and Mortality or Stroke. JAMA 2019;321:2193–2202.
25. Vincent F. et al. Transcatheter Aortic Valve Replacement in Bicuspid Aortic Valve Stenosis. Circulation Vol 143, No.10
26. Szerlip M et al. Transcatheter Aortic Valve Replacement in Patients with End-Stage Renal Disease. J Am Coll Cardiol. 2019 Jun 11;73 (22):2806-2815
27. Webb JG, et al. 3-Year Outcomes After Valve-in-Valve Transcatheter Aortic Valve Replacement for Degenerated Bioprostheses: The PARTNER 2 Registry. J Am Coll Cardiol. 2019;73:2647–2655.
28. Vahl T. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study The lancet. Vol 403;10435 p 1451-1459, April 13 2024
29. Garcia S. Et al. Treatment of Aortic Regurgitation With a Novel Device: Results of the J-Valve Early Feasibility Study. Jacc Interv vol 17 No 17 2024
30. PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR (PROGRESS) Clinicaltrials.gov NCT04889872
31. Marquis-Gravel G, Stebbins A, Kosinski AS, et al. Geographic Access to Transcatheter Aortic Valve Replacement Centers in the United States: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. JAMA Cardiol. 2020;5(9):1006–1010. doi:10.1001/jamacardio.2020.1725
32. Nishimura RA, et al. AATS/ACC/SCAI/STS Expert Consensus Systems of Care for TAVR. Journal of the American College of Cardiology. 2019;73:1209–1234.
33. Bavaria, J, et al. 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement: A Joint Report of the American Association for Thoracic Surgery, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. JACC. 2019 Jan, 73 (3) 340–374.
34. Vemulapalli S, et al. Procedural Volume and Outcomes for Transcatheter Aortic Valve Replacement. N Engl J Med. 2019;380:2541-50
35. Elbadawi A, et al. Clinical Outcomes in Relation to Total Hospital Surgical and Transcatheter Aortic Valve Replacement Volumes. J Am Heart Assoc. 2024 Oct; 13 (19):e035719
36. Badheka AO, et al. Operator Volume and Outcomes of Transcatheter Aortic Valve Replacement. American Journal of Cardiology. 2015;116:587–594.

Less

Dear CMS Leadership,
I support the request for CMS to update the TAVR National Coverage Determination to include all current and future FDA-approved indications. The current NCD, while valuable for safety, has become restrictive as evidence and technology have advanced.

Key recommendations:

1. Expand coverage to all FDA-approved indications to improve patient access and align with evidence-based practice.
2. Reinforce the Heart Team approach, explicitly including structural heart coordinators for patient navigation and care continuity.
3. Allow single-operator evaluations and procedures at the discretion of the facility-based heart team.
4. Eliminate facility volume requirements.

Timely access to TAVR for all appropriate patients, supported by a multidisciplinary team, is critical for improving outcomes and reducing disparities.

Thank you for your leadership in advancing care for Medicare beneficiaries.

Sincerely,
Jasmina Katinic

Less

I support CMS’s decision to re-evaluate the National Coverage Determination for transcatheter aortic valve replacement (TAVR) in light of substantial advances in device technology, procedural safety, and clinical evidence since the original NCD was established.

Multidisciplinary Heart Team care should remain a foundational requirement for TAVR, as it has been central to the therapy’s success and to maintaining high-quality outcomes nationwide. However, the current mandatory requirement for evaluation by a surgeon does not reflect practical and modern practices as care for patients who may require TAVR has evolved. I recommend transitioning to a competency- and case-based Heart Team model in which structured, documented multidisciplinary discussion is mandatory, while surgical involvement is required selectively based on anatomic complexity, clinical uncertainty, or surgical equipoise rather than by default in every case. This approach preserves rigorous oversight and patient-centered decision-making while reducing unnecessary barriers to access.

I also support expansion of coverage to carefully selected asymptomatic patients with severe aortic stenosis, informed by emerging randomized trial data demonstrating improved clinical benefit with early intervention compared with conservative management. Coverage policy should evolve alongside evidence and allow appropriately selected patients to benefit from therapy before the onset of irreversible myocardial damage or adverse clinical events.

Finally, I strongly support continued mandatory participation in the TVT Registry for all TAVR programs. Registry participation remains essential for ongoing quality assurance, real-world outcomes monitoring, and continuous quality improvement. CMS should continue to emphasize outcomes-based performance metrics and transparent reporting as the primary mechanisms to safeguard patient safety and accountability.

In summary, I encourage CMS to modernize the TAVR NCD by maintaining a robust multidisciplinary Heart Team framework, refining surgical evaluation requirements to better reflect contemporary practice, supporting evidence-based expansion of patient eligibility, and preserving registry-based quality oversight. These updates will protect patient safety, improve access to care, and align national coverage policy with the current state of TAVR practice.

Nabil Sabbak, MD
Interventional & Structural Cardiologist
Wellstar Center for Cardiovascular Care

Less

With respect to the issues under consideration:

Clinical evidence supporting early intervention for asymptomatic severe AS.

Data from the EARLY TAVR, EVOLVED-AS, AVATAR, and RECOVERY randomized clinical trials collectively demonstrate a clinical benefit of early aortic valve replacement—whether surgical or transcatheter—in patients with asymptomatic severe aortic stenosis. Earlier intervention has been shown to reduce heart failure hospitalizations and stroke, with consistent demonstration of safety across trials. Reflecting this evidence base, the 2025 ESC/EACTS Guidelines for the Management of Valvular Heart Disease expanded indications for AVR (Class IIa) to include patients with asymptomatic severe aortic stenosis. Accordingly, coverage of TAVR for appropriately selected asymptomatic patients who elect earlier intervention through a shared decision-making process is both justified and necessary.

Need for maintaining the NCDR TVT Registry.

The NCDR TVT Registry has served as a foundational platform for scientific inquiry, quality improvement, and longitudinal monitoring of clinical outcomes for TAVR and other transcatheter valve therapies. Since initial FDA approval, more than 800,000 commercial TAVR procedures have been performed and entered into the registry across approximately 850 centers. Throughout this period of rapid national expansion, data from the TVT Registry demonstrate appropriate utilization and consistently excellent outcomes, with continued improvement over time.

In 2024, the median age of patients undergoing TAVR was 79 years, with only 5% younger than 65, underscoring that utilization remains largely confined to an older, high-risk population. Contemporary outcomes are notable for an in-hospital mortality rate of approximately 1%, stroke rates of 1.4%, and new permanent pacemaker implantation rates of 7%, with emergent conversion to surgery now exceedingly rare. These outcomes reflect substantial technological evolution—now into fourth-generation devices—as well as a marked reduction in procedural complexity. Approximately 96% of procedures are performed via transfemoral access, most in the cardiac catheterization laboratory and under moderate sedation. Collectively, these data indicate that TAVR has become a highly generalizable therapy, with consistent safety and efficacy across a broad range of U.S. hospitals. Early concerns regarding inappropriate utilization or degradation in technical outcomes with widespread adoption have largely not been realized. While mandatory participation in the current TVT Registry structure has become increasingly burdensome for many centers and may no longer be justified given the consistently excellent clinical outcomes observed with TAVR, continued participation in a more streamlined registry framework would remain prudent should current NCD requirements be relaxed or eliminated, in order to ensure that further expansion of TAVR does not compromise patient outcomes.

Hospital and operator volume requirements.

Despite the widespread availability of TAVR nationally, access remains limited in many communities. Several U.S. states are served by a single TAVR center, leaving many rural patients hundreds of miles from a TAVR center. Extensive evidence demonstrates that barriers to care disproportionately affect rural populations and individuals of lower socioeconomic status. Given these persistent disparities, policy interventions aimed at improving access to TAVR are urgently needed.

The current NCD mandates minimum hospital and operator volume thresholds, many of which have not been consistently shown to correlate with procedural safety or outcomes. As procedural complexity has decreased and outcomes have improved, the continued necessity of several of these requirements is unclear. Chief among these is the requirement that both an interventional cardiologist and a cardiac surgeon jointly perform each TAVR procedure. Multidisciplinary heart valve teams remain foundational to high-quality TAVR programs; however, there is no evidence that the routine presence of both specialties is required for the safe execution of the procedure itself. Rates of emergent conversion to surgery during TAVR are now comparable to those seen with PCI, yet cardiac surgeons are uniquely mandated for TAVR but not for PCI or other transcatheter valve interventions. The migration of most TAVR procedures to the catheterization laboratory, coupled with demonstrated safety in this setting, further underscores the lack of need for intra-procedural surgical resources. The requirement for a cardiac surgeon to be present also represents a significant opportunity cost at many centers, where limited surgical resources may be diverted from open surgical cases. Ultimately, centers should retain the flexibility to determine the appropriate specialty mix and number of operators based on local expertise and resources. The critical determinant of quality is procedural expertise and experience, not specialty designation.

I would therefore strong advocacy for the removal of hospital and operator requirements, including both volume and specialty mandates. Such changes would eliminate unnecessary barriers to care, improve workforce efficiency, and meaningfully mitigate persistent geographic and socioeconomic disparities in access to timely, high-quality aortic stenosis care.

Less

1. The heart team (surgeons and cardiologists) being involved in decision making for patients is very valuable in many cases. The heart team should be able, at this level of TAVR historical maturity, to make those decisions for most patients without mandating formal surgical evaluation. Surgeons often make independent assessment for surgery outside of the heart team approach. These decisions can be similar to decision-making for PCI.
2. I fully support expanded coverage of TAVR for those with asymptomatic severe AS. The EARLY TAVR data is convincing and mimics what is experienced in current clinical practice.
3. I fully support 2 trained operators in every TAVR procedure. This can be any combination of IC's or surgeons with proper qualifications.

Less

Public Comment on Medicare Coverage for Transcatheter Aortic Valve Replacement (CAG-00430R2)
UCSF Team for High-Value Care

We appreciate the opportunity to comment on the reconsideration of the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR). For asymptomatic patients, as there is no evidence of mortality benefit or any other clinically meaningful outcomes, TAVR is neither reasonable nor necessary and should not receive Medicare coverage. TAVR is premature in these asymptomatic patients and will subject them to procedural risk, which includes death and stroke, risk of atrial fibrillation, and need for permanent pacemaker, without any benefits. Furthermore, as these tend to be younger patients, their remaining lifespan generally exceeds the known lifespan for the TAVR valves, which means a second and risky procedure. For symptomatic patients, we believe that Coverage with Evidence Development (CED) should remain in place to ensure continued data collection for this population.

Lack of Clinically Meaningful Benefit for Asymptomatic Patients

Patients with severe aortic stenosis are asymptomatic for many years and are at low risk for death during that time. [1] Since these patients feel well and are at low risk of death, improvements in clinical outcomes - mortality or stroke incidence - are needed to show benefit from intervention with TAVR. The recent randomized unblinded clinical trial of TAVR in asymptomatic patients, EARLY TAVR,[2] did not find any mortality or stroke benefit with intervention compared to clinical surveillance. Similarly, the EVOLVED trial,[3] a smaller study focused on a subset of asymptomatic patients with myocardial fibrosis, compared conservative management to intervention with either transcatheter or surgical aortic valve replacement and found no benefit on mortality for intervention.

EARLY TAVR did appear to show a reduction in heart failure hospitalizations and an improvement in quality-of-life measures, but these subjective findings are severely limited by the trial’s unblinded study design. In EARLY TAVR, patients, investigators, and the independent clinical events committee were aware of treatment assignments. Consequently, improvements in heart failure hospitalizations—which requires a subjective decision about the cause of hospitalization—and quality-of-life measures may reflect the placebo effect instead of actual improvement due to the intervention.

The apparent reduction in unplanned cardiovascular hospitalizations in EARLY TAVR is also driven by poor study design. It is not an actual benefit to patients. About 25% of the control arm converted to TAVR before 6 months. These conversions were counted as “unplanned” hospitalizations because symptoms developed soon after randomization, which led to conversion to TAVR, before planned monitoring at 6 months. One of the EARLY TAVR investigators, Hemal Gada, wrote about his concerns that the difference in unplanned hospitalizations is due to “subtraction anxiety” of control patients: patients became more aware of (or even developed) symptoms in response to feeling they “missed out” on TAVR by being randomized to the control group.[4] This is a major methodological flaw in this study. The EARLY TAVR authors do not explain why this group of patients, who all went an average of > 6 METS on an exercise treadmill test prior to randomization, so quickly developed symptoms after randomization to the control group. “Subtraction anxiety” likely explains this peculiar phenomenon in the non-intervention arm of the EARLY TAVR trial. As part of recruitment for such interventional trials, there is a lot of hype and build up for getting the device, and patients can feel they drew the short straw when they are not randomized to intervention. Dr. Gada explained that many patients joined the EARLY TAVR trial because they wanted to get a TAVR. The control group were told they could cross over or “convert” to TAVR if they developed any symptoms. It was in their interest, therefore, to develop symptoms—which were subjectively self-reported—and did in suspiciously high numbers.

CED for Symptomatic Patients

We believe that the CED requirement should be continued for symptomatic patients. Continued data collection for symptomatic patients—and public availability of this data—is essential. Currently, data collected within the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry is not publicly available.

Conclusion

As there is no evidence of clinically meaningful benefit for Medicare beneficiaries, TAVR for asymptomatic patients is not reasonable or necessary and should not receive Medicare coverage. To better understand long-term device performance, data collection for TAVR conducted in symptomatic patients should continue, and this data should be publicly available.

UCSF Team for High-Value Care
Sarah Tingley, MA
Rita Redberg, MD MSc

References
[1] Chizner MA, Pearle DL, deLeon AC Jr. The natural history of aortic stenosis in adults. Am Heart J. 1980;99(4):419-424. doi:10.1016/0002-8703(80)90375-0
[2] Généreux P, Schwartz A, Oldemeyer JB, et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2025;392(3):217-227. doi:10.1056/NEJMoa2405880
[3] Loganath K, Craig NJ, Everett RJ, et al. Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis: The EVOLVED Randomized Clinical Trial. JAMA. 2025;333(3):213-221. doi:10.1001/jama.2024.22730
[4] Walter M. Q&A: Cardiologist and EARLY TAVR co-author questions study’s execution. Cardiovascular Business. June 13, 2025. Accessed January 13, 2026. https://cardiovascularbusiness.com/topics/clinical/structural-heart-disease/tavr/cardiologist-early-tavr-asymptomatic-fda-approval

Less

January 13, 2026

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: NCA CAG-00430R2 Transcatheter Aortic Valve Replacement (TAVR)

Dear Administrator Oz,

Abbott welcomes the opportunity to comment on the National Coverage Analysis (NCA) for TAVR, CAG-00430R2, which was requested by Edwards Lifesciences. Abbott believes NCD policies should be revised as therapies mature and become standard of care. We encourage the Centers for Medicare & Medicaid Services (CMS) to adopt a more flexible, future-proof policy framework that empowers heart teams to make patient-centered decisions, fosters innovation, and ensures equitable access to life-saving therapies such as TAVR.

Specifically, Abbott requests that CMS consider the following:

1. Avoid restating the FDA-approved indications within the NCD. This will preserve policy agility and reduce the need for frequent NCD reconsiderations. As new evidence emerges and indications expand, maintaining coverage aligned with approved FDA indications – without duplicating specific indication wording in the NCD – will allow the policy to remain current and responsive to innovation.

2. Support clinical flexibility in intraprocedural requirements. This will allow local Heart Teams to make the best decision for individual procedures, such as number of operators and physician specialties.

3. Permit telehealth for pre-procedural patient evaluations. Allow telehealth visits to improve access for patients in rural or underserved areas. Allowing telehealth versus face-to-face visits would be at the discretion of the Heart Team.

4. Reduce / remove institutional requirements. Institutional volume requirements and hospital staffing criteria may create unintended barriers to care—particularly in rural or underserved areas. As practice patterns and procedure volumes continue to change over time (such as PCI volume migration to ASCs), institutional volume thresholds may no longer reflect true institutional capability and could inappropriately disqualify hospitals. Removing volume and program staffing requirements would reduce access barriers.

5. Remove clinical study trial coverage criteria section B. CMS has released numerous final national coverage determinations with the language, “Nothing in this NCD would preclude coverage of [therapy] through NCD 310.1 (Clinical Trial Policy) or through the Investigational Device Exemption (IDE) Policy.” Abbott supports the TAVR NCD to be updated with this language for clinical trial coverage as it allows for flexibility in trial design and streamlined review under existing review processes.

6. Provide clarity on conditions for CED. Clear and transparent standards for altering or discontinuing CED criteria should be provided. Such a framework should also consider clarity on how to incorporate new patient populations as appropriate.

Thank you for your consideration of our comments. We look forward to continuing to collaborate with the Agency on refinements to this NCD.

Sincerely,

Peter Kelly
DVP Corporate Reimbursement Government Affairs
Abbott

Less

I am writing in support of continued Medicare coverage for TAVR and to strongly recommend that the NCD preserve the multidisciplinary Heart Team reimbursement model, allowing for meaningful participation by both an interventional cardiologist and a cardiac surgeon.

TAVR is now a standard, high-value therapy across risk strata, but it remains a procedure that requires the skill set of both a cardiologist and Cardiothoracic surgeon. A joint cardiology–cardiac surgery Heart Team is not administrative overhead; it is a patient-safety standard that improves decision quality, anticipates procedural risk, and ensures immediate access to surgical expertise when needed.

Weakening or eliminating the team requirement risks reintroducing siloed practice patterns and competition for referrals, potentially misaligning incentives away from patient-centered selection and outcomes.

I encourage CMS to continue supporting access to TAVR while explicitly reaffirming that coverage is tied to a true multidisciplinary model—where both specialties are actively involved in evaluation, planning, and procedural readiness. Preserving this structure will protect beneficiaries and sustain the quality gains achieved in TAVR outcomes nationwide.

Less

There are no other technologies that have been as transformational to the cardiovascular space as TAVR has been in the last 10 years. The trials have been very enlightening to both surgeons and cardiology with new understanding of what is acceptable and reproducible for outcomes that help pts live better lives. We have a better understanding of frailty and concomitant disease that helps us make recommendations to pts to help them get the most out of their and our resources.
Our hospital system is still very involved with industry and were one of the primary investigators for most the early and continuing trials. I have been the lead quality person for our program for the last 12 years and have been on the board at the Michigan Society of Cardiovascular Surgery, which is our state society that meets quarterly to share unblinded data of all our patients before the data is sent to STS and TVT. In general, our state does an excellent job of quality and are doing better than the national average in both TAVR and aortic valve surgery. But even in an open setting we do notice trends - There is often an under reporting of complications in low volume programs – recent papers report that not having a stroke team in your hospital leads to underreporting of post op CVA. At the state level, we do not always all agree on best practices but have had many discussions that have led to various protocol changes on ways to improve care over the years.
I am concerned that the proposed changes that have been brought forward could lead to less innovation and poor use of our limited health care resources. Recent data shows that about half of the TAVR valves placed in the US are put in pts under 65 years of age. The European guidelines are recommending 70 years of age. There have been three recent papers by large institutions showing that the redo AVR after TAVR has a mortality of 14 -20%, compared to redo AVR after SAVR having the same risk as the first procedure in the recent STS risk calculator. When thinking about what is good for society this creates an already alarming trend. Without the heart team approach we may miss out on opportunities to maximize the use of our resources (examples treating concomitant a.fib, CAD or other valvular issues in pts that are low or intermediate risk ). There are other times that pt with small anulus and low risk may be better off with TAVR than with SAVR even with root enlargement or root replacement. I am concerned that we (cardiology and surgery) may not be able to give informed consent without a heart team approach.
There may be more pressure on cardiology to use femoral access when an alternative access may be the better choice if no surgeons are involved. This also takes surgeons out of the loop for bailout and if they are only called for emergencies over time their skill set will deteriorate making risky cases even more difficult.
Although the current system is not perfect I feel most comfortable knowing that family and friends scattered across the US have the advantage of having a team approach and if something does not turn out as well as expected or a few months later someone realizes that something was missed we would at least have the comfort that it was not just one person having a bad day that created a less than desirable outcome. We are very supportive of industry but this seems more like a push from industry to grab uninformed pts and maximize profit margins in the short term.
This is not just getting another stent this is an aortic valve procedure. Would you trust that possibly the biggest decision of your life would be made after only talking to one person? I think we can do better than that. There needs to be checks and balances to keep us all held accountable. Thank you for taking the time to listen to my position and please feel free to contact me if you have any questions or want further information.
Sincerely,
Justin Fanning.

Less

Re: National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR) CAG-00430R2

We appreciate the opportunity to provide feedback on the important matter concerning the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). Below are our consolidated comments as the Washington University in St. Louis Structural Team.

1. **Heart Team Approach**

2. **TAVR Operator Requirements**

3. **Expansion of Coverage to Asymptomatic Aortic Stenosis**

4. **Continued Coverage with Registry Oversight**

We appreciate your consideration of our comments.

Sincerely,

Structural Heart Team, Washington University in St. Louis
Tsuyoshi Kaneko, Division Chief, Cardiothoracic Surgery
Alan Zajarias, Medical Director, Structural Heart Program

Less

January 13, 2026
Dear Administrator Mehmet Oz,
On behalf of Consumer Action for a Strong Economy (CASE), a leading voice for pro-growth, free-market policies that support American consumers, I appreciate the opportunity to comment on the Administration’s examination of federal health policies that significantly affect patient access, provider participation, and the healthcare marketplace.

CASE supports policies that promote competition and support a thriving American economy and opposes those that impose needless regulations that impost unnecessary barriers without delivering meaningful benefits. In keeping with these principles, CASE believes the Centers for Medicare & Medicaid Services’ (CMS) continued reliance on Coverage with Evidence Development (CED) represents an overly restrictive and outdated policy tool.

In accordance with these values, CASE believes the usage of Coverage with Evidence Development (CED) by the Centers for Medicare & Medicaid Services (CMS) is an unnecessary, overly burdensome policy. When applying for CED, CMS uses enrollment in a clinical trial as a prerequisite for coverage of a treatment, even though the treatments are already approved by the Food and Drug Administration (FDA). For many patients—particularly those who are older, medically fragile, or living in rural or underserved communities, this requirement functions less as evidence collection and more as a barrier to care. When mobility is limited and access to trial sites is constrained, CED can effectively delay or deny treatment altogether.

The treatment in question, the transcatheter aortic valve replacement (TAVR) National Coverage Determination (NCD), has been labeled a “gold standard” example of CED. CASE disagrees with this categorization. TAVR is a well-established, minimally invasive treatment for a life-threatening condition, supported by years of robust clinical trials and real-world outcomes data. With data proving this treatment is safe and effective, readily available use of CED in this procedure is wasteful and unnecessary. The procedure has transformed care for patients who may not be good candidates for open-heart surgery, offering faster recovery times, fewer complications, and meaningful improvements in quality of life.

CED was originally intended to help close limited evidence gaps for emerging or uncertain therapies. Applying it to FDA-approved, widely adopted treatments with demonstrated safety and effectiveness distorts that purpose and risks discouraging innovation while limiting patient choice. CASE urges CMS to reexamine the use of CED in coverage determinations. This is particularly important in the case of life-saving treatments such as TAVR that have ample evidence to support their usage and coverage. Removing CED from the TAVR NCD would be a vital first step towards aligning CMS policy with the goal of adopting a more market-conscious approach to balance evidence needs with access, competition, and economic sustainability. Throughout government-sponsored health plans, CED should be carefully examined and possibly eliminated altogether to ensure that senseless restrictions don’t impede access.

American consumers deserve fair access to necessary treatments without burdensome regulations. In line with CASE’s commitment to oppose regulations that impose costs on everyday Americans without providing a clear benefit, we believe the continued use of CED in the TAVR NCD undermines patient care and the overall effectiveness of the healthcare system.

Thank you for your time and consideration.

Sincerely,
Gerard Scimeca
Chairman & General Counsel
Consumer Action for a Strong Economy (CASE)

Less

January 13, 2026

Centers for Medicare & Medicaid Services
Coverage and Analysis Group
7500 Security Boulevard
Baltimore, MD 21244

RE: CAG-00430R2 NCD Coverage Reconsideration for Transcatheter Aortic Valve Replacement

Dear CMS Members of the Coverage and Analysis Group:

I am writing on behalf of the cardiac surgeons at Northwestern Medicine to provide comments on the current CMS open National Coverage Determination (NCD) reconsideration for Transcatheter Aortic Valve Replacement (TAVR) Procedure.

Our comments will focus on safety and long-term benefits.

1. Patient Safety
There have been requests to remove the requirement for cardiac surgeons to be present and/or be removed from the shared decision-making process as to whether an aortic stenosis patient should be treated with TAVR or open surgical valve repair/replacement (SAVR). We disagree that the current NCD should be changed and that surgeons should be removed from the decision-making and procedure. There is a need for a surgeon to be present for the potential emergent complications and patient risk undergoing TAVR. Patients who present with multiple comorbidities (heart failure, atrial fibrillation (AF), etc.), those who have complex anatomies, or those with major vascular bleeding, damage to blood vessels, or acute kidney issues may need surgical intervention, and the lack of a surgeon present at the time of TAVR could place the patient at higher risk. As an example, in a recent study, major bleeds were present in 6.6% of TAVR patients during the procedure, and higher in those on dual anti platelets (12.2%).¹ Those with major bleeds had 14% odds of mortality in the first 30 days following TAVR, versus a risk of 4% in those without major breeds (p<0.001). Surgeons are the only ones trained to help assess and treat these potential complications in real time.

There have also been questions about the widespread use of TAVR for various populations, requirement for higher pacemaker rates with TAVR, and needing additional safety data, such as the comparison TAVR vs. SAVR in younger patients (<70 yrs) and BAVs, and Valve-in-Valve (V-in-V) for failures, focusing on long-term durability.² These are important considerations since over 100,000 patients undergo TAVR each year in the US, and many sub populations have worse outcomes than others.³ Assessing risk-benefit of this procedure is paramount.

2. Patient Outcomes
Studies have shown mixed results when comparing TAVR and SAVR outcomes, but both show positive patient improvements. In our opinion, surgical treatment options are best identified by surgeons as part of the aortic stenosis treatment shared decision-making process (as opposed to interventionalist alone). A recent comparison study showed a significantly lower rate of long-term mortality with SAVR,^4,5 including those with lower ejection fraction and heart failure.⁶ highlighting the importance of comorbid conditions. Those with comorbid conditions require additional care during and following treatment. As an example, those with untreated AF (not treated with ablation during TAVR) during TAVR do worse than those without AF undergoing TAVR, and AF is an important predictor of the composite end point of all-cause mortality, stroke, vascular complications, and repeat hospitalization in 1 month after the procedure.⁷ Untreated AF is associated with a 1.5-2x hazard ratio for post intervention mortality whether the AF is preexisting or post intervention.⁸

Importantly, recent studies demonstrate better SAVR outcomes in those treated with a concomitant surgical ablation compared to TAVR with untreated AF.^9,10 In our own hands we have demonstrated the safety and outcomes of adding concomitant surgical ablation for AF during SAVR which did not impart additional patient risk following SAVR.¹¹ If it is possible to treat 2 pathologies in one operation (aortic stenosis, AF), we believe CMS would want to encourage concomitant treatment to improve patient outcomes and reduce the downstream costs, making a more-wise use of CMS beneficiary dollars. A recent emphasis of CMS has been the encouragement of treating concomitant procedures, including AF in one setting to improve patient outcome (MS-DRG 233, 234, 212). This is critically important since approximately 1 in 3 aortic stenosis patients present with preoperative AF and could have their AF treated during SAVR,¹² reducing the need for follow up treatment (medications, catheter ablation, percutaneous LAA).

In closing, we believe it is critical that surgeons remain involved in the hospital patient shared decision making to ensure guideline driven, best in class treatments are offered to patients. This included being present during the TAVR procedure to mitigate against serious complication risk. We also think it is critical that some form of the CMS NCD remains in place for patients at higher risk for long term outcomes risk (mortality, stroke) related to preexisting comorbid conditions (heart failure, stroke) to ensure long term outcome is considered for special populations beyond short term procedure risk.

Sincerely,

Patrick M. McCarthy, M.D.
Executive Director, Bluhm Cardiovascular Institute

Vice President, Northwestern Medical Group
Heller-Sacks Professor of Surgery
Northwestern University Feinberg School of Medicine
Northwestern Medicine

cc: Douglas R. Johnston, M.D.; James L. Cox, M.D.; S. Chris Malaisrie, M.D., Duc Thinh Pham, M.D.; Chris K. Mehta, M.D.; Benjamin S. Bryner, M.D.; Melissa G. Medina, M.D.; Kevin Hodges, M.D.; Stephen F. Chiu, M.D.; Gyu Gang, M.D.; Erhan Guler, M.D.; Aqeel A. Sandhu, M.D.; Ricardo B. Garibo, M.D.; Franjo Siric, M.D.

References
1. van Nieuwkerk AC, et al. Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors. JACC Cardiovasc Interv. 2023;16(24):2951-2962.
2. Miller DC. Expanding Transcatheter Aortic Valve Replacement Use in Younger Patients and Bicuspid Valves: Risks, Evidence Gaps, and Regulatory Action. Ann Thorac Surg. 2025;119(6):1166-1174.
3. Bowdish ME, et al. The future direction of post-transcatheter aortic valve replacement re-interventions: insights from the Society of Thoracic Surgeons National Database. Ann Cardiothorac Surg. 2025;14(2):151-153.
4. Park DY, An S, Kassab K, Jolly N, Attanasio S, Sawaqed R, Malhotra S, Doukky R, Vij A. Chronological comparison of TAVI and SAVR stratified to surgical risk: a systematic review, meta-analysis, and meta-regression. Acta Cardiol. 2023; 78(7):778-789.
5. Warner ED, Riley J, Liotta M, Pritting C, Brailovsky Y, Jimenez D, Chatterjee A, Tchantchaleishvili V, Rajapreyar IN. Aortic Valve Replacement in Patients With ESRD and Heart Failure With Reduced Ejection Fraction. Am J Cardiol. 2023;205:111-119.
6. Alabbadi S, Malas J, Chen Q, Cheng W, Tam DY, Cohen RG, Bowdish ME, Egorova N, Chikwe J. Guidelines vs Practice: Surgical Versus Transcatheter Aortic Valve Replacement in Adults =60 Years. Ann Thorac Surg. 2025;119(4):861-869.
7. Maan A, Heist EK, Passeri J, Inglessis I, Baker J, Ptaszek L, Vlahakes G, Ruskin JN, Palacios I, Sundt T, Mansour M. Impact of atrial fibrillation on outcomes in patients who underwent transcatheter aortic valve replacement. Am J Cardiol. 2015;115(2):220-6.
8. Petersen JK, Fosbøl EL, Strange JE, Schou M, Brems DA, Køber L, Østergaard L. Impact of first-time detected atrial fibrillation after transcatheter aortic valve replacement: A nationwide study. Int J Cardiol Heart Vasc. 2023 Jul 6;47:101239.
9. Mehaffey JH, et al. Atrial Fibrillation Management During Surgical vs Transcatheter Aortic Valve Replacement. Ann Thorac Surg. 2024;118(2):421-428. 10. Patrick WL, Chen Z, Han JJ, Smood B, Rao A, Khurshan F, Yarlagadda S, Iyengar A, Kelly JJ, Grimm JC, Cevasco M, Bavaria JE, Desai ND. Patients with Atrial Fibrillation Benefit from SAVR with Surgical Ablation Compared to TAVR Alone. Cardiol Ther. 2022;11(2):283-296.
11. Churyla A, Andrei AC, Kruse J, Cox JL, Kislitsina ON, Liu M, Malaisrie SC, McCarthy PM. Safety of Atrial Fibrillation Ablation with Isolated Surgical Aortic Valve Replacement. Ann Thorac Surg. 2021 Mar;111(3):809-817.
12. Lowenstern A, et al. Association of Transcatheter Aortic Valve Replacement Reimbursement, New Technology Add-on Payment, and Procedure Volumes with Embolic Protection Device Use. JAMA Cardiol. 2022;7(9):945-952.

Less

On behalf of millions of taxpayers and consumers across the country, the Taxpayers Protection Alliance applauds the Centers for Medicare & Medicaid Services (CMS) for opening its reconsideration of its National Coverage Determination on Transcatheter Aortic Valve Replacement (TAVR). This minimally invasive treatment to treat patients with aortic stenosis is significantly more affordable for taxpayers and patients than traditional alternatives and expanding treatment to asymptomatic patients will save lives and reduce Medicare spending. TPA urges CMS to adopt commonsense reimbursement policies in line with comprehensive clinical evidence guidelines and sound fiscal stewardship.

TAVR is an innovative approach to treating aortic stenosis, a life-threatening narrowing of the heart’s aortic valve that disproportionately affects older Americans. Unlike traditional Surgical Aortic Valve Replacement (SAVR), which requires open-heart surgery and cardiopulmonary bypass, TAVR allows physicians to replace the valve through a catheter inserted into a blood vessel, typically in the groin. This approach avoids major surgery, reduces physiological stress on patients, and has expanded treatment options for elderly and higher-risk populations whose treatments account for most of Medicare’s $1 trillion budget.

Clinically, TAVR has demonstrated outcomes that are often superior to open surgery. Large, randomized trials and real-world registry data show similar survival rates, faster symptom relief, and more rapid improvements in quality of life, particularly for older patients and those at intermediate or high surgical risk. Patients undergoing TAVR generally experience fewer complications related to surgical trauma, such as major bleeding or prolonged ventilator use, which are common drivers of extended hospital stays and downstream costs. A 2024 review of the evidence published in the medical research journal Cureus concludes, “TAVR is preferred over SAVR in terms of cost-effectiveness across a variety of patients with other coexisting medical conditions, including cancer, advanced kidney disease, cirrhosis, diabetes mellitus, and bundle branch block. TAVR also appears to be superior to SAVR with fewer post-operative complications.”

Unsurprisingly, the reduced length of stay and diminished likelihood of complications translate to significant savings for taxpayers and patients. According to a 2019 analysis published in Circulation—an American Heart Association journal—“Over a lifetime horizon, TAVR was projected to lower total costs by $8000 to $10 000 and to increase quality-adjusted survival by 0.15 to 0.27 years.” These findings are consistent with Edwards Lifesciences’ 2024 Early TAVR study, which focused on asymptomatic patients in particular and found improved outcomes following early intervention with TAVR. When the abundance of evidence all points in one direction, it is critical that Medicare listens and updates its reimbursement policies accordingly.

TPA further encourages CMS to remove its coverage with evidence development (CED) determination for TAVR and scale back CEDs as part of a wider reform effort. When first put into place via 2005 and 2006 CMS guidance, CED was designed to allow Medicare to verify the effectiveness of new treatments covered by the insurance program. CMS ordinarily employs the “reasonable and necessary” standard for covering treatments, but this standard may not be met by premarket trial data alone. CED data collection ideally serves as a way of closing the evidentiary gap, particularly when the treatment is off label (i.e., not approved by the Food and Drug Administration (FDA) for a particular use).

Unfortunately, CED policy has not lived up to its promise, even blocking treatments approved by the FDA with a wealth of clinical trial data. As healthcare policy advisor and researcher Joe Grogan noted in 2023, “with the advent of a new class of Alzheimer’s treatments, CMS has now for the first time applied this policy to therapies when used on-label, effectively inserting itself as a ‘check’ on the [FDA].” CMS has also used the overly bureaucratic CED process to hamper access to CAR-T cell therapy and continuous glucose monitors, leaving Medicare patients vulnerable to an increasingly unaccountable program. When used to monitor certain cancers, Positron Emission Tomography (PET) scans are still subject to a 2005 CED requirement. TAVR is just another proven treatment in a long line of medical breakthroughs shackled by this unnecessary and outdated process.

CMS should reform the CED program to only encompass therapies not approved by the FDA for relevant uses being considered by Medicare. This change would ensure that CED is not a costly regulatory add-on to already-onerous FDA rules. By reforming CED determinations and shifting course on TAVR reimbursements, CMS could save patient lives and help stabilize Medicare’s finances. Thank you for your time and consideration of these important issues.

Less

I support expanding coverage for transcatheter aortic valve replacement (TAVR) in appropriately selected patients with asymptomatic severe aortic stenosis, particularly as emerging evidence demonstrates benefit with earlier intervention in preventing disease progression and adverse outcomes. As clinical practice and data continue to evolve, coverage policy should reflect contemporary, evidence-based care.

While I strongly support the heart team model and multidisciplinary evaluation as essential components of high-quality valve care, the current National Coverage Determination (NCD) creates a significant barrier to access by requiring both a cardiothoracic surgeon and an interventional cardiologist to participate in each TAVR procedure. This procedural requirement exceeds what is necessary to ensure quality and safety and does not reflect current practice patterns in experienced, high-volume TAVR programs.

The mandatory dual-operator requirement limits patient access, contributes to delays in care, and creates unnecessary operational constraints—particularly in regions with limited surgical availability—without clear evidence of improved outcomes. Importantly, these access limitations are magnified for asymptomatic patients, for whom timely intervention may prevent irreversible cardiac remodeling and downstream morbidity.

I respectfully encourage CMS to revise the NCD to maintain rigorous heart team evaluation and shared decision-making while allowing procedural flexibility based on institutional experience and outcomes. Such an update would improve access, support patient-centered care, and better align coverage policy with current clinical evidence and real-world practice.

Less

I am a cardiothoracic surgeon with 25 years of experience, currently serving as Director of the Cardiothoracic Surgery Program for our healthcare system and an integral member of our structural heart program performing ~300 TAVR procedures annually. I have experienced the evolution of TAVR since its inception and have seen firsthand why its national success has depended on disciplined patient selection, program capability, and accountability. CMS has reopened the TAVR NCD for reconsideration (CAG-00430R2) [1], following an industry request that seeks, among other changes, to reduce or remove key coverage conditions [2]. In my opinion, it would be a mistake to prioritize industry-driven simplification over the realities faced by operators and the systems responsible for outcomes, complications, and rescue care.

CMS is specifically reassessing whether existing “treatment conditions” remain necessary to achieve outcomes comparable to those seen in clinical studies [1]. I strongly believe the answer is yes. The core guardrails—a surgeon-integrated multidisciplinary Heart Team, mandatory audited registry participation, and site capability/experience requirements—are patient-safety protections, not administrative barriers. Diluting these requirements will not meaningfully improve true access; instead, it will predictably increase marginal-case expansion into centers with limited resources and limited rescue capability. The volume–outcome relationship for TAVR has been clearly demonstrated, with higher and more variable 30-day mortality in low-volume hospitals [3]. CMS should modernize the NCD where evidence supports it, but must not dismantle the framework that made TAVR safe at national scale.

Finally, structural-heart experience outside the aortic valve should be a cautionary precedent. When multidisciplinary safeguards are weakened, patients often return later needing urgent, complex surgery after ill-indicated or poorly selected percutaneous interventions—at higher risk and with fewer durable options. After failed mitral TEER, surgical repair is infrequently achievable and most patients require replacement, underscoring how initial decision-making can irreversibly narrow future options [4]. In the tricuspid space, randomized data show meaningful symptom and quality-of-life improvements after tricuspid TEER [5], but transcatheter tricuspid valve replacement remains associated with non-trivial early hazards (e.g., in TRISCEND II, 1-year severe bleeding ~15% and new permanent pacemaker ~17%, and a measurable early safety signal) [6,7]. These realities reinforce—not diminish—the need for CMS to maintain Heart Team governance, audited registry reporting, and program capability standards. If CMS removes TAVR guardrails, we will see a parallel rise in inappropriate utilization and late surgical salvage—without any credible evidence that patients will be safer or better served.

References
1 - Centers for Medicare & Medicaid Services. National Coverage Analysis (NCA) Tracking Sheet: Transcatheter Aortic Valve Replacement (TAVR), CAG-00430R2 (NCA ID 321). Public comment period 12/15/2025–01/14/2026.
2 - Edwards Lifesciences. Request to Reconsider NCD 20.32 for Transcatheter Aortic Valve Replacement (TAVR) (request letter dated 07/28/2025).
3 - Vemulapalli S, Carroll JD, Mack MJ, et al. Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. N Engl J Med. 2019;380:2541-2550. doi:10.1056/NEJMsa1901109.
4- Chikwe J, et al. Mitral Surgery After Transcatheter Edge-to-Edge Repair: Society of Thoracic Surgeons Database Analysis. J Am Coll Cardiol. 2021.
5 - Sorajja P, et al. Transcatheter Repair for Patients with Tricuspid Regurgitation (TRILUMINATE Pivotal). N Engl J Med. 2023.
6 - Hahn RT, et al. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation (TRISCEND II). N Engl J Med. 2025;392(2):115-126. doi:10.1056/NEJMoa2401918.
7 - American College of Cardiology. TRISCEND II Trial Summary (EVOQUE TTVR): key 1-year safety findings (bleeding and pacemaker rates). Posted Oct 30, 2024.

Respectfully submitted,
Juan B Grau, MD, FACS, FACC
Director, Cardiothoracic Surgery Program
The Valley Hospital Health Care System
Professor of Surgery
The University of Ottawa Heart institute

Less

My concern with the proposal as written is the proposition for single implant approval. The goal of this is clearly driven by cardiology to dissolve the requirement of having cardiothoracic surgery involved in evaluation and treatment of these patients. I feel this is largely driven by smaller institutions where in planters with minimal cardiothoracic support would like to continue to implant in the absence of CT surgery. This would be the greatest disservice to the advancement of cardiovascular health over the last 20 years. The greatest gift that’s been given to cardiac care over. The last decade is the institution of the Heart Team. This was mandated via CMS requirements of having both cardiothoracic and interventional cardiology participate in both the evaluation and treatment of these patients. This results in a very balanced approach to both surgical and interventional treatment of aortic disease in these patients. This is created a close knit community between interventional cardiology and CT surgery that not only benefits these specific patients but the entirety of the cardiovascular line as these relationships, mandate, frequent face-to-face contact and discussion. At a larger volume implant center. It is in frequent that we get through two entire clinics where one patient should not be diverted to surgery away from Taver, which in the absence of cardiothoracic input would result in inappropriate Taver implantation. And this is Long before we even approach the safety of a single implanter. While there is data that high volume planters who are replacing multiple hundreds of taverns a year can implant these relatively safely with minimal extra support. This will largely be utilized at small volume centers where implanter lack the skill and experience to implant these safely by themselves. As this device cannot be deployed by a single person in a safe manner and does require two people which means you’re replacing a skilled and knowledgeable operator with a scrub tech who lacks the ability to make last-minute adjustments. The advancement of Taver is a modality of treatment and the safety efficacy of it would be greatly undermined by the dissolution of this team. I would employ this committee to take careful consideration into the rapid and safe expansion of this modality of treatment as evidence that two minds are greater than one and the dissolution of the Heart Team to allow for single implanter treatment of aortic disease would be the greatest undermining of cardiovascular care in recent memory.

Less

TAVR operators experience has come a long way over the last 15 years. Both interventional cardiologists and cardiac surgeons who developed expertise in TAVR are capable of attaining safe outcomes independently. While ongoing intraprocedural collaboration is always welcome it is not always possible due to restraints of staffing and conflicting responsibilities. Moving to a mandate of 2 qualified operators rather than requiring 1 interventional cardiologist and 1 cardiac surgeon would enhance patient access to therapy and improve operational efficiencies without compromising procedure safety and outcomes. The primary TAVR operator (an interventional cardiologist or a cardiac surgeon) should be able to conduct the procedure with any other qualified physician (a cardiac surgeon or and interventional cardiologists).

With respect to the use of TAVR in asymptomatic patients with severe aortic valve stenosis, it is clear from the current available evidence that this approach is safe and effective in preempting cardiac decompensation. While it is also evident that asymptomatic patients would not be at an increased risk of death if they are closely followed and treated promptly when they become symptomatic close follow up is not always feasible. Therefore, it stands to reason to provide coverage for TAVR in asymptomatic patients with certain caveats to implement this strategy in selected patients.

Less

January 13, 2025

Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Administrator Mehmet Oz,

Thank you for the opportunity to provide feedback on federal health policy frameworks that greatly impact patient access to care and for reopening the conversation around unnecessary coverage approval processes. I appreciate your leadership as the Administration considers how regulatory structures can support innovation while ensuring optimized access for patients across the country.

My name is John Czwartacki. I have been living with my chronic disease for more than 30 years and have relied on access to cutting-edge treatments throughout the past three decades to treat my disease. I was first diagnosed with [PHI Redacted] when I was early in my career on Capitol Hill, barely a year after I graduated from college. With my adult life ahead of me, I was hopeful that American innovation would soon develop an effective treatment. Thankfully, the system worked in my favor, and I was able to receive access to four separate breakthrough treatments that have given me my career, family, and quality of life.

I started Survivors for Solutions to advocate on behalf of patients living with chronic, rare, and life-threatening illnesses and to preserve and protect the medical innovations that give patients like me hope. Our project, Access for All, works to ensure patients can access these new developments once they are created by examining current policies that may or may not prevent patients from accessing life-altering treatments.

With this goal in mind, Access for All strongly feels Coverage with Evidence Development (CED) policy, utilized by Centers for Medicare & Medicaid Services (CMS), poses a significant threat to patient access. The policy can often be a barrier to patient access rather than a bridge to better evidence. By requiring patients to be enrolled in studies to receive coverage for devices and treatments that have already been approved by the Food and Drug Administration (FDA), this policy directly delays or denies care to rural and mobility-restricted Medicare beneficiaries who cannot always participate in trials or registries.

Concerningly, the transcatheter aortic valve replacement (TAVR) National Coverage Determination (NCD) is often cited as a “gold standard” example of CED. This characterization deserves closer scrutiny. CED should be removed from NCD for TAVR to protect access to this minimally invasive treatment that can be crucial for patients with damaged heart valves.

The TAVR NCD has been in place for nearly a decade, despite the existence of a large amount of evidence to answer the original coverage questions posed by CMS. The presence of CED in TAVR NCD highlights that these requirements are often used where they are not scientifically needed and where evidence shows a treatment is safe and effective. The TVT Registry is touted for quality data collection. However, it should not be the “gold standard” for patient access.

CED participation also has high costs for providers, further threatening patient access. High enrollment fees, additional costs from staffing hours, and administrative burdens can put participation out of reach. This means that the patients relying on providers who cannot meet these requirements are effectively kept from getting the treatment they need.

As this administration considers future applications of CED and its approach to CED in general, I urge a careful examination of what truly constitutes a patient-centered, evidence-based approach. Coverage approval policies need to reflect scientific evidence and prioritize efficient, effective access to innovation. Using CED in the TAVR NCD—as well as for any treatment approvals—works against these goals. Thank you for your attention to this important issue.

Best regards,

John “CZ” Czwartacki
Founder & Chairman
Survivors for Solutions and Access for All
www.survivorsforsolutions.org
www.campaign4access.com

Less

To Whom It May Concern,

Thank you for the opportunity to comment on the National Coverage Analysis for Transcatheter Aortic Valve Replacement (TAVR). As a practicing interventional cardiologist specializing in structural heart disease (SHD), I strongly support continuation of the TAVR National Coverage Determination under Coverage with Evidence Development (CED), with targeted updates that reflect the maturity of this therapy and its expanding indications.

Expansion of Coverage and Future-Proofing the NCD
Medicare coverage should be expanded to include the newly FDA-approved indication for asymptomatic severe aortic stenosis. The evidence supporting early intervention is compelling, and Medicare beneficiaries should not face delayed access to therapies that are safe, effective, and evidence-based. More broadly, modernizing the NCD language to broaden rather than narrow, indication-specific terminology would allow the policy to evolve alongside FDA approvals, including valve-in-valve procedures, aortic regurgitation, moderate aortic stenosis, and future transcatheter innovations.

Multidisciplinary Heart Team and Procedural Flexibility
The success of TAVR has been built on the multidisciplinary heart team model. High-quality outcomes depend on dedicated expertise, focused training, and longitudinal experience among interventional cardiologists and cardiac surgeons who are actively engaged in structural heart care. This team-based approach should remain foundational to the NCD.

To support access while preserving quality, greater flexibility in defining the intraprocedural operator team is warranted and should be aligned with existing NCDs for mitral and tricuspid transcatheter therapies. Allowing the local multidisciplinary heart team to determine whether procedures are supported by one interventional cardiologist and one cardiac surgeon, or by two experienced interventional cardiologists, based on local expertise, resources, and outcomes, would streamline care delivery while maintaining accountability through outcomes-based monitoring rather than prescriptive staffing requirements.

Coverage With Evidence Development and Outcomes-Based Oversight
Continued CED remains essential. While TAVR is a mature therapy, indications and technologies continue to expand. Mandatory participation in a national, audited registry is critical to ensuring that real-world outcomes match clinical trial results, to guiding patient selection, and to informing future policy decisions. In this setting, outcomes-based metrics should be prioritized, with procedural volume serving as a contextual rather than primary indicator of quality.

Structural Heart Disease Fellowship Training and Workforce Development
Sustaining high-quality outcomes as transcatheter therapies expand requires a highly trained and specialized workforce. SHD is now a core component of interventional cardiology and minimally invasive heart surgery, encompassing a wide range of complex transcatheter technologies across multiple valve platforms.

Despite this complexity, SHD fellowship training has existed outside of ACGME accreditation for nearly 15 years. As the field continues to evolve, formal ACGME accreditation, along with the appropriate funding, of SHD fellowship training is increasingly necessary to ensure standardized education, competency assessment, and consistent preparation of future members of the multidisciplinary heart team. Medicare policy plays a critical role in signaling the importance of workforce development early in the life cycle of emerging specialties. Supporting structured SHD training aligns directly with CMS priorities by promoting procedural proficiency, reducing complications, improving long-term outcomes, and ultimately enhancing cost-effectiveness through avoidance of preventable adverse events and repeat interventions.

Conclusion
This NCD decision carries significant implications for Medicare beneficiaries. A policy that expands access to appropriate patients, maintains high standards through outcomes-driven oversight, preserves the multidisciplinary heart team model but removes prescriptive staffing requirements, supports continued evidence development, and recognizes the importance of formalized and funded SHD training pathways will best serve patients and the healthcare system as transcatheter therapies continue to advance.

Thank you for your consideration and for your continued commitment to evidence-based, patient-centered care.

Sincerely,
Chad Kliger, MD

Less

Thank you for considering the abundance of evidence that supports TAVR as a safe and beneficial procedure for patients with and without symptoms associated with aortic stenosis.

We have seen the progression of the TAVR process and procedure from the early inoperable patients requiring a tremendous number of clinical resources, screening and preparation towards a more sustainable model that is reproducible in more hospitals but limited by the requirements of the outdated NCD. As the TAVR procedure evolves to require fewer resources, the NCD needs to evolve as well.

The development of the Heart Team has been of tremendous benefit for the patients we serve and the clinicians who collaborate to provide the best care plans for our patients. We also need to allow the Heart Team to evolve, triaging patients needed for additional discussion and screening and allowing the more straightforward cases to proceed more quickly to procedure.

The volume of patients who could benefit from TAVR is largely untapped. We have objective measures to determine severe aortic stenosis, why are we willing to watch and wait until the subjective symptoms appear before we offer a proven intervention to patients that preserves heart muscle and quality of life. Patients would be outraged if they understood their treatment options are limited by the containment of resources tied to the outdated NCD causing backlogs and delays due to the strain on resources which limit the number of procedures we can offer.

In my career, I have worked as an administrator in a large academic medical center and community hospitals large and small. To meet the patient demand for AS treatment, it is our obligation to find ways that hospitals with fewer resources may be able to assist with the looming volume of patients who can benefit from a TAVR procedure. As the TAVR procedure continues to be further refined and the outcomes continue to be positive, the current NCD prevents community adoption and expansion of a procedure that is safe and effective. A revised NCD that utilizes quality metrics and outcome oversight along with more flexible standards that allow hospitals to utilize the mix of provider talent they have available; we can make a difference for our patients.

Thank you for your careful consideration of revisions to the TAVR NCD.

Less

I believe that TAVR in asymptomatic patients is potentially harmful for Medicare beneficiaries and there is no evidence of benefit. In my opinion, it should not receive Medicare coverage. The rationale for my opinion is based on the following:
1. Patients with severe aortic stenosis are asymptomatic for many years and are at low risk for death during that time.
2. Since these patients are not currently experiencing symptoms and are at low risk of death, improvements in clinical outcomes, such as mortality or stroke incidence, are needed to show that TAVR will benefit this population.
3. EARLY TAVR, the largest and most recent randomized controlled trial to study TAVR in asymptomatic patients, did not show mortality or stroke benefit.
4.i The unblinded study design of EARLY TAVR was problematic. In EARLY TAVR, patients, investigators, and the independent clinical events committee were aware of treatment assignment, and therefore improvements in heart failure hospitalizations, which require a subjective decision about the cause of hospitalization, and quality of life measures may reflect the placebo effect instead of actual improvement due to the intervention.
4.ii. The reduction in unplanned hospitalizations in EARLY TAVR was driven by about 25% of the control arm converting to TAVR before 6 months. These conversions were counted as "unplanned" hospitalizations because symptom development and conversion occurred before planned monitoring at 6 months. The early conversions, and the difference in unplanned hospitalizations, is likely due to "subtraction anxiety" of control patients. This means that patients in the control group, knowledgeable of their assignment (to not receive TAVR or "TAVR subtracted), may become more aware of symptoms in response to feeling as though they "missed out" on TAVR by being placed in the control group. This is a well described effect in non-blinded intervention trials.
5. Since there is no evidence of clinically meaningful benefit, TAVR for asymptomatic patients is not "reasonable and necessary" and should not receive Medicare coverage.
Thank you, Andrew Foy, MD

Less

I am a structural interventional cardiologist at a high-volume TAVR program performing more than 500 procedures annually. I have been in practice for five years and appreciate the opportunity to comment on the national coverage determination for transcatheter aortic valve replacement (TAVR).

First, it is no longer necessary to require that both a cardiac surgeon and an interventional cardiologist independently examine and evaluate every patient being considered for TAVR to determine suitability for TAVR versus surgical aortic valve replacement (SAVR). Our surgical colleagues are not required to seek interventional cardiology input prior to every SAVR, nor are interventional cardiologists required to obtain a surgical consultation prior to every percutaneous coronary intervention. In both circumstances, physicians appropriately seek additional opinions when clinically indicated. The TAVR community can be trusted to apply the same judgment. Mandatory dual evaluation for every patient adds administrative burden without clear benefit to patient outcomes.

Second, it is no longer necessary to require both a cardiac surgeon and an interventional cardiologist to jointly participate in every TAVR procedure. All currently available TAVR platforms require two operators for safe valve deployment, and in my opinion both should remain physicians. However, this does not necessitate that one operator be a cardiac surgeon. Team composition should be left to the discretion of individual programs based on experience, case complexity, and outcomes. At our institution, procedures requiring advanced catheter and wire skills—such as valve-in-valve TAVR or leaflet modification techniques—are often best performed by two interventional cardiologists. In these cases, mandatory surgical participation may not represent the most effective use of expertise or resources. That said, I strongly support the continued requirement that TAVR be performed at sites with on-site surgical backup.

Finally, I support expanded coverage for TAVR in patients with asymptomatic severe aortic stenosis. While symptom status has historically guided timing of intervention, contemporary evidence supports earlier treatment in appropriate patients. The EARLY TAVR trial demonstrated that an early TAVR strategy in asymptomatic patients significantly reduced the composite endpoint of death, stroke, or unplanned cardiovascular hospitalization compared with clinical surveillance, driven largely by fewer heart failure hospitalizations. These findings suggest that waiting for symptoms may expose patients to avoidable morbidity and support coverage for earlier intervention in certain patients.

Thank you for your consideration of these comments and for your continued efforts to align coverage policy with evolving evidence and clinical practice.

Sincerely,
Laura Flannery, MD, FACC, FSCAI

Less

Dear Administrator Oz,

We are writing to provide commentary and recommendation on the current open National Coverage Determination (NCD) reconsideration for Transcatheter Aortic Valve Replacement (TAVR) Procedure. TAVR has demonstrated overall good results and improved the life of many patients. However, we are concerned about TAVR patients undergoing intervention for aortic stenosis (AS) who also present with Atrial Fibrillation (AF) and the failure to offer optimal treatment (concomitant surgical ablation, STS Class I Recommendation) simultaneously during TAVR and leaving patients at a higher risk for cardiovascular events in follow-up.

Our comments will focus on the risk-benefit assessment in CMS beneficiaries who present with AF at the time of the TAVR index procedure, which has been reported to be around 36% in a recent analysis of the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) registry (1). In our opinion, CMS policy should allow provider flexibility to offer best patient care, but also inclusive of Society Guidelines, quality impact and available evidence.

AF is an atrial rhythm disturbance and known risk factor for increased mortality, 5x stroke risk and worsening heart failure (2). Opportunities to treat AF beyond medical management concomitantly when performing cardiac procedures are recommended by the Society Thoracic Surgeons with Class I Guidelines (3). One recent study illustrated the benefit of concomitant treatment of AS and AF in one index visit. Patrick et al. (2022) compared the 5-year benefit of treating TAVR with untreated AF and open surgical aortic valve replacement (SAVR) with concomitant open SA for AF at the time of index. Through 5 years, concomitant open SAVR and SA imparted a risk-adjusted 35% (HR; 0.65) lower chance of mortality compared to TAVR with untreated AF (P<0.01), and 38% (HR; 0.062) lower chance of pacemaker insertion during follow-up (P<0.01) (4). This study demonstrates that for complex AS patients who present with AF at the time of index, concomitant procedures that include open SAVR and SA for AF during the index may improve outcomes better than TAVR with untreated AF in the medium and long term follow-up period.

We, therefore, ask CMS to critically review medium- and long-term outcomes and risk benefit in Medicare beneficiaries who are being treated for AS and simultaneously present with AF, and maintain the NCD to ensure shared decision making is included with a cardiac surgeon for AF patients to ensure SAVR with concomitant SA is one treatment option being offered.

1. Background

Aortic stenosis (AS) has a reported prevalence of 1% to 2% in patients aged 65 or less and up to 29% in patients aged 65 or more (5). AS is treated with a variety of therapies including medical management, open surgical aortic valve replacement/repair (SAVR), and transcatheter aortic valve replacement (TAVR) with varying outcomes (6). TAVR has become a common treatment with hospital procedure volume growing in the US from approximately 4,000 procedures to over 98,000 procedures during 2012 to 2022 (7). This represents at minimum, a CMS hospital spend of $46,610 (2026: MS-DRG 266; $54,907, 38% cases; MS-DRG 267, $43,494, 62% cases; Table 1) per index stay (8), and if 85% of TAVR procedures are performed with Medicare beneficiaries, there would be an annual CMS spend of more than $3.8 billion in MS-DRG payments before any physician fees are added. In our analysis, device and supply costs represented approximately 70% of the hospital spend during the index stay from TAVR device costs (>$30,000/per device) (8-9), and with newer devices approaching more than $40,000 per device.

There is currently a CMS NCD in place for TAVR coverage, which is under review for changes, based on updated literature and guidelines. We have concerns about the impact of changing the NCD on patient outcomes in those who present with significant comorbid conditions such as atrial fibrillation (AF) at the time of TAVR, and who are only discharged with medical management (untreated AF during TAVR index), when the patient maybe a candidate for SAVR and concomitant surgical ablation (SA) for AF (2 pathologies treated simultaneously). We are also concerned about the implication of TAVR over treatment if the NCD is modified and less cardiac surgeon involvement is required in shared decision making.

2. AF Impact on Increasing TAVR Index Cost and Worsening Patient Outcomes

AF is a complex progressing disease, which increases AF and risk for several other conditions, such as heart failure, stroke, and all-cause mortality (10). Up to 12 million Americans will be diagnosed with AF by 2030 (11). AF is such an important treatment and mortality consideration, CMS has created multiple concomitant MS-DRG (212, 233, 234, 317) to allow SA to be performed with contemporary cardiac procedures (CABG, Double Open Valves, and Left Atrial Appendage Management) to mitigate the risk of AF and minimize the need for future patient procedures to treat AF. For the discussion below, we define untreated AF during TAVR as follows:

3. Untreated AF during TAVR index definition: Those who present with both aortic stenosis and atrial fibrillation at the time of the TAVR index visit, and eligible for treatment of 2 medical conditions with open surgical aortic valve replacement and concomitant open surgical ablation during the same index visit, but instead treated for only 1 medical condition (aortic stenosis) with TAVR and discharged without treating AF during the index, and the AF being managed long term with medical mgmt.)

Rao et al. (2025) recently observed that TAVR patients with untreated AF during the index procedure added over $2,000 to the hospital index visit costs compared to TAVR patients who did not present with AF worsening hospital economics (p<0.001). Potential drivers of higher costs in the untreated AF TAVR group included a significantly higher major adverse event rates; 27% greater odds of acute heart failure, 38% greater odds cardiogenic shock, and 20% greater odds acute bleed potentially related to anti-coagulant use for arrhythmia management (12). A second study by Patil et al. (2020) confirmed similar rates of higher adverse events during the TAVR index stay associated with untreated AF patients, including 36% greater odds of acute stroke (p=0.02) and 1.3 days longer length of hospital stay (6.2 d vs. 4.9 d, p <0.0001) (13). These results suggest that medically managing untreated AF during a TAVR stay takes up even more valuable hospital resources, in addition to device costs.

Our complete findings of our MEDPAR analysis are contained in Table 1. We used standard cost to charge ratio methodology to convert charges into costs.

Table 1. TAVR Index Costs and Average Length of Stay w/woAF, in which AF is Untreated

MS-DRG	TAVR Admission w/o AF (N)	TAVR Admission w AF (N)	Total Avg Index Costs	Supply/ Device Costs As a % of Total Costs	ALOS
266	11,050		$52,564	66.1%	3.8
266		8,640*	$54,662	62.2%	5.0
267	23,539		$42,197	75.8%	1.4
267		10,952	$42,562	74.86%	1.7
266-267	34,589		$45,510	72.27%	2.2
266-267		19,592	$47,895	68.51%	3.1

*Source: Based on FY2024 Final MedPAR data and modeling of FY2026 Final IPPS rule
**Performed by Watson Analytics

In the Medicare beneficiary analysis, AF was present in 36% of index stays. Those TAVR procedures with untreated AF present had an incremental index cost of $2,385 and increase in hospital length of stay of 0.9 days. Supply and device costs represented 62-75%% of hospital costs depending on MS-DRG placement.

In addition to acute index impact, untreated AF during TAVR has medium-long term clinical risk and financial implications.

4. Long Term Increased Clinical Risk in those with AF Untreated following TAVR

Mentias et al. (2019) examined the impact of preexisting AF (41% of cohort) for TAVR patients, and those that developed post-intervention AF (4% of cohort) compared to those had no-AF through index TAVR-post procedure. The follow-up was for 3 yrs. Those that presented with AF or developed AF post TAVR index procedure demonstrated significantly longer ICU stay, higher acute stroke rates, and longer average length of hospital stay (p<0.001). At 30-day post intervention, and a common time period for CMS quality metrics, those with any AF had significantly greater heart failure, stroke, or bleed related readmission, and greater 30-day all-cause mortality (p<0.001). A similar trend was noted at 3 yrs, with all-cause mortality almost double for TAVR patients with untreated AF (mortality rate as 22.6/100) than the non-AF TAVR patients (mortality rate as 12.8/100 patient yrs) (p<0.0001) (14). In a second study a similar trend was noted by Arrotti et al. (2024) who found a higher all-cause mortality at 3 yrs for those with untreated AF at the time TAVR (35.6%) versus those without AF at the time of TAVR (27.2%) (P<0.01) (15). Collectively, these results suggest that the presence of AF has a significantly higher clinical risk/impact on patient outcome and TAVR procedure cost, and the risk benefit of TAVR in follow-up with untreated AF versus other treatments should be considered along-side surgical risk for those who present with AF and AS.

5. Higher CMS Costs in those with AF Untreated Following TAVR

Management of AF with medical management as opposed to treating with surgical/catheter ablation to terminate AF and reduce symptoms and embolic risks has shown to be a costly endeavor. See et al. (2025) examined a cohort of over 3 million Americans from the Medical Expenditure Panel Survey, the largest all payor data base which provides annual costs of AF management (16). Average age of those in the study with AF was 71 years, and after adjustment the authors found an incremental yearly spend of $6,185 per person. The authors further concluded an overall national healthcare expenditure of $22.1 billion per year related to AF management. If the average CMS beneficiary lived an additional 10 years following TAVR with untreated AF management during index, and remained on medical management, this would add an additional $61,850 healthcare expenditure per patient (10 yr * $6,185/yr). If 36% of CMS beneficiaries undergoing TAVR were discharged with untreated AF, this would potentially add ~$188 million in annual AF treatment costs (30,547 beneficiaries * $6,185/yr), or an additional ~$2 billion over a 10-year horizon. Certainly, if 2 medical conditions (AS and AF) are present and could be treated in one index visit to improve patient outcome such as mortality risk and reduce healthcare cost, this should be a consideration.

6. Benefit Analysis: Treating AF Stenosis and Leaving AF Untreated during TAVR or Treating Both AS and AF with Open SAVR with Concomitant SA

Patients requiring interventions to treat AS have options such as TAVR or SAVR. Many patients would prefer a minimal invasive procedure such as TAVR, but those who present with multiple pathologies may benefit greater when multiple pathologies can be treated in one episode of care. Payment policy should be structured to allow those benefiting the most to have the most efficacious treatment.

Those with TAVR and untreated AF remain at significant risk for stroke and mortality if the AF is only managed medically post discharge. Providers must decide which treatment pathway is best in these circumstances. We present below a selective summary of published literature comparing the clinical benefit of TAVR with untreated AF versus those undergoing SAVR with concomitant surgical ablation for AF.

Study 1: TAVR with Untreated AF during index versus concomitant SAVR + SA to treat AF during index

In a retrospective study with over 2,200 propensity matched patients in either TAVR patients with untreated AF or SAVR with SA for AF during index observed several clinical benefits in favor of the SAVR with SA group through 5 years (3). Readmission rates were greater for TAVR with untreated AF related to greater HF admits (51%), greater bleeding admits (37%), and greater pacemaker implant (38%), and all p<0.01. Restoration of normal sinus rhythm with additive ablation is thought to improve ejection fraction and overall heart failure (17). All-cause mortality rate was 52% for TAVR with untreated AF versus 30% for SAVR with SA through 5 years (p<0.01). Hazard ratio showed a significant time effect in favor of SAVR with SA versus TAVR with untreated AF, with lower mortality over time, and greatest divergence beginning around year 2, suggesting better long-term mortality benefit when treating both AS and AF with concomitant SAVR with SA versus TAVR for AS with untreated AF.

[FIGURE AVAILABLE UPON REQUEST Please contact MCDFeedback@cms.hhs.gov]

Study 2: TAVR with Untreated AF during index versus concomitant SAVR + SA to treat AF during index

In a retrospective study, Mehaffey et al. (2024), reviewed a cohort of 24,902 patients compared those presenting with AF, treated with either TAVR with untreated AF (n=17,453), or SAVR with untreated AF (n=4,273), and those with SAVR and AF treatment (surgical ablation or surgical LAAM)(n=3,176) (18). During the index visit SAVR with AF treatment had 42% lower readmits in the first 30 days for stroke than TAVR with untreated AF (p<0.001), but higher overall 30-day readmit driven by higher HF readmit rates (p<0.001). Importantly, by the 3-yr follow-up period SAVR with AF treatment compared to TAVR with untreated AF demonstrated reduced risk for all-cause mortality (21%) and reduced stroke readmit (32%) (p<0.001). Isolated SAVR alone also had a 22% reduced rate in stroke readmit risk compared to TAVR with untreated AF as well (22%) (p<0.001). Hazard Ratio’s showed lower mortality over time in favor of SAVR with AF treatment during index (see Figure 2 below), and the greatest divergence beginning approaching year 2, suggesting better mortality benefit when treating both AS and AF with concomitant SAVR with SA/LAAM versus TAVR with untreated AF.

[FIGURE AVAILABLE UPON REQUEST Please contact MCDFeedback@cms.hhs.gov]

In addition to demonstrating better longitudinal patient outcome with SAVR and concomitant AF ablation compared to TAVR with untreated AF, we examined the economic impact of the two scenarios, longitudinally to assess economics of spend. We included as scenario 1, TAVR index + untreated AF estimated incremental costs over 5 years, versus 2. Isolated SAVR with surgical ablation for AF, and costs over 5 years.

If we make some extrapolations on cost benefit of potential spend longer term, we can assume the following:

Table 2. Cost Estimates of Index TAVR with Untreated AF and Index Isolated SAVR with Treated AF through 5 Yr Follow-up

Procedure	Index Hospital Spend	% of Index Spend Represented by Device/Supply Costs	AF Incremental Spend Yearly	5 YR Index and AF Related Costs to CMS
TAVR w Untreated AF	$47,833	$6,185	$78,758
SAVR with Treated AF with Surgical Ablation	$73,019	————	$73,019

*Index spend from CMS 2024 MEDPAR Data, Watson Analytics

In reviewing MEDPAR data, index spend is higher for SAVR when treating 2 medical conditions, than TAVR when leaving AF untreated. If we assume that AF is treated successfully with SA, then the untreated AF for TAVR would most likely require more resource use each year for AF management. If we model this out through 5 years, there would be an average increased AF healthcare spend of over $5,739 per TAVR patient who has untreated AF during index, based on data from Arrotti et al (2024)(12). Together with improved clinical benefit, and lower patient longitudinal mortality risk, AS patients that present with AF should be given consideration for SAVR with concomitant SA treatment for AF during index for the best use of Medicare beneficiary spend.

7. Recommendations

We appreciate the opportunity to comment on this important topic. Over $3.8 billion annually is spent on TAVR procedures by CMS, and it is important to ensure finite resources are spent wisely. Approximately 1/3 of TAVR patients present with AF, with increased stroke and mortality risk. Very few of these eligible AF patients are offered treatment for this progressive disease at the time of index. Untreated AF during the presentation of TAVR, when left untreated would typically progress and cost CMS more to treat in the future. Treating AF more aggressively than medical management during index with AS treatment may infer a better clinical risk. We suggest the following:

8. Conclusion

In closing, we appreciate the opportunity to provide commentary to CMS on the important topic of the existing TAVR NCD. Given the clinical impact on patients, and total annual expenditure by CMS, it is critical to ensure beneficiaries are provided with optimum care and wise use of finite dollars. We believe there is opportunity to modify the NCD to allow continued data collection and shared decision making on the most comorbid patients, who are at risk for stroke and mortality risk for medium and long term if there is a history of AF or present at index. Specifically, we believe those patients treated with TAVR with AF/history, w/wo HF should be maintained in the NCD, to better assess when TAVR or SAVR is most appropriate for these patients. We thank you for consideration of these comments.

References

1. Lowenstern A, et al. Association of Transcatheter Aortic Valve Replacement Reimbursement, New Technology Add-on Payment, and Procedure Volumes With Embolic Protection Device Use. JAMA Cardiol. 2022;7(9):945-952.
2. Wolf PA, et al. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991;22(8):983-988.
3. Wyler von Ballmoos MC, et al. The Society of Thoracic Surgeons 2023 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation. Ann Thorac Surg. 2024;118(2):291-310.
4. Patrick WL, et. al. Patients with Atrial Fibrillation Benefit from SAVR with Surgical Ablation Compared to TAVR Alone. Cardiol Ther. 2022;11(2):283-296.
5. Coffey S, et al. The prevalence, incidence, progression, and risks of aortic valve sclerosis: a systematic review and meta-analysis. J Am Coll Cardiol. 2014;63(25 Pt A):2852-61
6. Coisne A, et al. ACC/AHA and ESC/EACTS Guidelines for the Management of Valvular Heart Diseases: JACC Guideline Comparison. J Am Coll Cardiol. 2023;82(8):721-734.
7. Bowdish ME, et al. The future direction of post-transcatheter aortic valve replacement re-interventions: insights from the Society of Thoracic Surgeons National Database. Ann Cardiothorac Surg. 2025;14(2):151-153.
8. 2026 Watson Analytics. Based on FY2024 Final MedPAR data and modeling of FY2026 Final IPPS rule
9. https://www.thecardiologyadvisor.com/news/tavr-vs-savr-aortic-stenosis-which-procedure-has-greater-savings/
10. Inciardi RM, et al. Risks of Heart Failure, Stroke, and Bleeding in Atrial Fibrillation According to Heart Failure Phenotypes. JACC Clin Electrophysiol. 2023;9(4):569-580.
11. Kornej J, et al. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020;127(1):4-20.
12. Rao A, et al Perioperative outcomes of atrial fibrillation in patients undergoing transcatheter aortic valve replacement: a national inpatient sample study. Int J Cardiol Heart Vasc. 2025;59:101688.
13. Patil N, et al. Trends and effect of atrial fibrillation on inpatient outcomes after transcatheter aortic valve replacement. Cardiovasc Diagn Ther. 2020;10(1):3-11.
14. Mentias A, et al. Impact of Pre-Existing and New-Onset Atrial Fibrillation on Outcomes After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2019;12(21):2119-2129.
15. S. Arrotti, et al. Atrial fibrillation before and after transcatheter aortic valve implantation: short- and long-term clinical implications, J. Cardiovasc. Med. 2024;25(1):51.
16. See C, et al. Healthcare Expenditure on Atrial Fibrillation in the United States: The Medical Expenditure Panel Survey 2016 to 2021. JACC Adv. 2025;4(5):101716.
17. Ad N, et al. The impact of surgical ablation in patients with low ejection fraction, heart failure, and atrial fibrillation. Eur J Cardiothorac Surg. 2011;40(1):70-6.
18. Mehaffey JH, et al. Atrial Fibrillation Management During Surgical vs Transcatheter Aortic Valve Replacement. Ann Thorac Surg. 2024;118(2):421-428.

Less

To CMS:

I welcome and appreciate the opportunity to comment on the proposed updates to Medicare coverage for transcatheter aortic valve replacement (TAVR).
Having been involved in the TAVR procedure since initial commercial inception in December 2011, it has been gratifying watching this grow from a controversial, carefully regulated procedure for high/extreme risk only patients into a standard of care and routine treatment for all-risk patients with severe AS.

In the light of our clinical experience over the last 14 years, the CMS guidelines have evolved as well, and it is clearly time for a refresh to reflect current data and to address some of the limitations of the current structure. This will help meet the CMS goals of improving patient care, patient access, patient safety, and impact on limited resources. Having run large structural programs both in an urban and now large rural area, some of the mandatory requirements have outlived their clinical utility and impose significant clinical and logistical burdens on patients, families, and providers.

Recommendations:
1. Recommend eliminating need for redundant and burdensome office visits. The requirement for a mandatory additional independent face to face encounter with a surgeon frequently imposes significant burdens on the elderly TAVR patient population in terms of logistics on both the patient and provider sides, only sometimes adds to management, and often leads to delay in care. Delay in access to TAVR has repeatedly been associated with increased mortality. Dual separate visits should be reserved for clinically appropriate circumstances, not a blanket requirement. A single visit with either the IC or CS Heart Team member should suffice for evaluation.

Note that there is no similar requirement for SAVR, where the surgeon is not asked to have an IC review the case for surgical approach.

The Heart Team and valve conference should still function and evaluate all candidates in a multidisciplinary forum.

2. Recommend eliminating requirement for mandatory co-surgeon for TAVR procedure. The TAVR procedure can easily be done as a solo operator, who can be either an IC or CS. Rates of conversion to open procedures are less than that of PCI, which in uniformly performed in hospitals on a daily basis without surgical team physical presence in the cath lab. The presence of onsite surgical backup and the heart team evaluation provide a well thought out back up plan for the rare emergency.

Requiring a second operator carries with it significant burden to the host institution, reducing coverage in the cardiac OR or cath lab, and consumes unnecessary resources. For some smaller institutions or even larger institutions with limited cardiac surgery operators, this requirement takes a CS out of the OR and can result in significant delays in operative time for patients requiring open surgery. We do MTEER, TTEER, LAAO closure and other similar procedures with single operators (IC or CS), and TAVR should be no different.

3. Recommend expanding indications to include asymptomatic severe AS. Randomized controlled trials (EARLY TAVR, EVOLVED and others) have shown safety and efficacy of TAVR in patients with severe AS who are not yet symptomatic. Allowing Heart Team assessment and intervention in this population with TAVR where the clinical team feels beneficial is very reasonable and should be adopted.

Thank you for your consideration

Paul Mahoney, MD FACC, FSCAI
Professor and Chief, Interventional Cardiology
Director Structural Heart Programs
East Carolina University Health

Less

We appreciate the opportunity to provide comments regarding the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). Since the original adoption of NCD 20.32, TAVR has undergone substantial evolution in technology, procedural technique, patient selection, and outcomes. Contemporary evidence supports revisiting certain structural and procedural requirements to ensure continued access to high-quality care while minimizing unnecessary patient burden and preserving program integrity.

1. Institutional Program Standards

We support maintaining existing institutional program requirements for TAVR. These standards have been instrumental in ensuring procedural quality, multidisciplinary oversight, and favorable patient outcomes across risk categories.

Supporting Evidence:

STS/ACC TVT Registry Annual Reports demonstrate sustained improvements in mortality, stroke, vascular complications, and length of stay over time.
Carroll JD et al. J Am Coll Cardiol. 2020;76:2492–2516.
CMS NCD 20.32 outcomes analyses.

2. Cardiac Surgery Consultation Requirements

For patients older than 65 years, surgical consultation should be obtained when clinically indicated based on anatomical complexity, procedural risk, or anticipated need for surgical intervention.
For patients older than 75 years, routine surgical consultation is not supported by contemporary evidence and may impose unnecessary physical, logistical, and emotional burdens without demonstrable benefit.

Modern TAVR practice is characterized by extremely low rates of emergent surgical conversion, particularly in transfemoral procedures using current-generation devices.

Supporting Evidence:

STS/ACC TVT Registry reports surgical bailout rates consistently below 1%.
Mack MJ et al. PARTNER 3 Trial. N Engl J Med. 2019;380:1695–1705.
Popma JJ et al. Evolut Low Risk Trial. N Engl J Med. 2019;380:1706–1715.
Baron SJ et al. Outcomes in elderly TAVR populations. Circulation. 2019.

3. Role of the Multidisciplinary Heart Team

We strongly support the continued requirement for a multidisciplinary heart team in all TAVR programs. The heart team model is essential for appropriate patient selection, shared decision-making, procedural planning, and longitudinal care.

However, heart team participation should be defined by substantive involvement in case review and decision-making rather than mandatory physical presence of all disciplines during each procedure.

Supporting Evidence:
2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.
CMS NCD 20.32 rationale for heart team involvement.
Holmes DR et al. J Am Coll Cardiol. 2015;65:2605–2615.

4. Registry Participation and Data Reporting

We strongly support continued mandatory participation in the STS/ACC TVT Registry. Registry-based surveillance has been central to improving outcomes, ensuring post-market safety, and informing evidence-based policy decisions.

Supporting Evidence:
STS/ACC TVT Registry used by CMS and FDA for coverage and post-approval surveillance.
Vemulapalli S et al. JAMA. 2019;321:2193–2202.

5. Procedural Staffing Requirements

Procedural staffing requirements should allow flexibility while maintaining safety and quality. Acceptable staffing models should include either:

Two qualified cardiac structural interventionalists, or
One qualified cardiac structural interventionalist and one cardiac surgeon.

Given the rarity of open surgical conversion in contemporary TAVR practice, routine physical presence of a cardiac surgeon during the majority of TAVR procedures does not provide incremental benefit beyond participation in heart team discussions. Availability of a cardiac surgeon within the institution is sufficient and consistent with standards applied to other high-risk catheter-based cardiovascular procedures.

Supporting Evidence:
STS/ACC TVT Registry surgical conversion rates <1%.
Minimalist TAVR outcomes: Babaliaros VC et al. JACC Cardiovasc Interv. 2014.
Complex PCI standards with on-site but not in-room surgical availability.

6. Reimbursement Considerations

We recommend reevaluation of TAVR reimbursement to reflect the increasing complexity of care delivery. Contemporary TAVR programs involve extensive pre-procedural imaging, frailty assessment, multidisciplinary coordination, peri-procedural management, and longitudinal follow-up in increasingly elderly and comorbid populations. Current reimbursement does not adequately account for these cognitive, logistical, and resource-intensive components of care. The primary cardiac structural interventionalist should receive a bigger proportion of the reimbursement rather than splitting it in half.

Supporting Evidence:
CMS episode-of-care cost analyses for TAVR.
Arnold SV et al. Resource utilization and cost trends in TAVR. J Am Coll Cardiol. 2021.
Economic analyses demonstrating mismatch between reimbursement and care complexity.

We respectfully urge CMS to modernize the TAVR National Coverage Determination to reflect contemporary evidence, procedural safety, and patient-centered care, while preserving the core elements that have ensured quality and accountability. These updates will enhance access, reduce unnecessary burden on elderly patients, and sustain high-quality outcomes across Medicare beneficiaries.

Thank you for the opportunity to provide these comments.

Less

Tamara Syrek-Jensen, JD
Director
Coverage & Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR) CAG-00430R2

Dear Ms. Syrken- Jensen:

I have read carefully the above referenced document, and I would like to offer the following comments:

1. The data supporting AVR in asymptomatic patients is robust and justifies coverage of this indication. Recent data suggests that even patients presenting with progressive symptoms (as opposed to acute valve syndromes) experience increased mortality and hospitalizations for heart failure (PMID: 40321310). While arguments can be made over whether every asymptomatic patient should be treated before eventual symptom development, this decision is nuanced and best left to the patient and their heart team.

2. CED mandate.

a. The request to reconsider the NCD for TAVR 20.32 correctly identifies the fact that many of the questions designed to be addressed through the CED have been satisfactorily answered. Still, since 2019, TAVR has continued to evolve and a central, mandatory repository of data could go a long way towards addressing questions which were not at the forefront 6 years ago. Questions related to TAVR-in-TAVR durability and outcomes, TAVR in patients under the age of 65 (a population thus far not explored in formal clinical trials but where TAVR now represents the dominant form or AVR), TAVR in bicuspid valves (a pathology more prevalent in younger, healthier patients), TAVR in ESRD patients (a population generally excluded from randomized clinical trials) could be answered by continued centralized data collection. Safety signals (PMID: 39412793 can also be identified and hopefully explored further / acted upon.

3. Barriers to care for TAVR cases

a. TAVR in 2026 can indeed be, for most cases, a single physician operator procedure.
b. Having said this, in my opinion, perhaps the biggest contribution of TAVR to modern cardiac care has been the introduction of the “Heart-Team” approach to the management of complex decision making. While TAVR was initially only available to patients deemed inoperable or at high surgical risk, TAVR is now routinely being offered to low surgical risk patients, patients under the age of 65 and patients for whom it is reasonable to anticipate the need for 2 or more subsequent biological heart valves. In this context, the role of the heart team is more important than ever especially as it pertains to first valve selection (TAVR vs SAVR) but also subsequent interventions (TAVR-in-TAVR, TAVR-in-SAVR, SURPLUS, Leaflet-Modification, TAVR explant etc.) I fear that the removal of the 2nd operator from the TAVR procedure could weaken the Heart-Team which in turn may lead to substandard patient care and introduce competition between cardiologists and cardiac surgeons in a manner detrimental to the lifetime management of aortic stenosis.
c. At a minimum, if the participation of a 2nd physician in the TAVR procedure is no longer mandatory, I believe multidisciplinary consultation (CT surgery and interventional cardiology), virtual or in person, should remain a requirement before the procedure. As outlined above, multidisciplinary consultation should offer patients not only a diversity of opinions but also access to more in-depth lifetime management considerations beyond the immediate procedure. Furthermore, for centers which elect to continue a dual operator approach, the current payment scheme allowing payment for two co-surgeons should be maintained.
d. While the outcomes of TAVR do not seem to have been affected during the COVID pandemic when a PHE exemption was in place, it remains unclear how many programs availed themselves of the exemption by moving to single operator TAVR – and in how many cases they did so.
e. TAVR (and overall AVR) access for underserved populations is a major concern and many factors contribute to this situation. In large metropolitan areas like the one where I am based, it appears doubtful that the loosening of the NCD requirements would lead to the opening of additional TAVR centers or truly increase access to care. Many urban areas are over-saturated with low volume TAVR programs and adding additional programs appears unlikely to occur, or be beneficial. To dramatically increase access, hospitals can already foster more streamlined TAVR procedures (PMID: 40894375), move the procedure out of the hybrid OR to the cardiac cath lab (PMID: 40851295), waive the requirement for on-site cardiac surgical team backup (PMID: 41346262) and develop outcome-based spoke-and-hub referral networks (PMID: 37017940). More controversially, arguments could be made to move the procedure to hospitals not offering open heart surgery (an approach already taken in other countries) or even office-based labs. Perhaps the most important action that could be taken to increase access to care would be to better match the value offered by TAVR (in terms of cost savings, Quality of Life, Length of Stay etc.) with commensurate reimbursement. Many hospitals and health systems continue to cite the limited contribution margins of TAVR when compared to SAVR as a reason to not allocate more resources to this revolutionary therapy. Counterintuitively, improvement in TAVR efficiency and the performance of TAVR in healthier populations could lead to further reductions in payment. The low reimbursement for TAVR together with “the varied trends in TAVR adoption that arise from market failures, differential reimbursement policies, and program requirements predispose the procedure to generating and perpetuating racial, geographic, and socioeconomic inequities in access to TAVR” (PMID: 35021854).

Sincerely,

Andrei Pop MD, FACC, FSCAI, RPVI Interventional Cardiology,
System Structural Director, Ascension Illinois
Cardiac Cath Lab Director, Ascension Alexian Brothers Medical Center.

Less

To whom it may concern:

I would like to respectfully submit comments for CMS to consider updating the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).

CMS should consider four key updates to the NCD:

1. Add coverage for asymptomatic severe aortic stenosis (AS)
2. Sunset the Coverage with Evidence Development (CED) requirement
3. Eliminate procedural volume requirements
4. Remove outdated staffing requirements, including the mandate for two cardiothoracic surgeons, dual consults, and co-surgeon participation

Each recommendation is supported by robust clinical evidence, contemporary guidelines, and real world outcomes, as outlined below.

1. Add Coverage for Asymptomatic Severe Aortic Stenosis

As illustrated by Braunwald’s curve (circa 1968), clinical experience, and the EARLY TAVR trial, aortic stenosis patents can rapidly deteriorate from asymptomatic to symptomatic, resulting in poorer outcomes, including death, and higher total cost of care to the healthcare system, patients, and Medicare itself. Often patients, including my father, who was a study patient and received his TAVR in 2015, hide symptoms from family and clinicians. Increasingly, time constraints between the clinician and patient make an exhaustive assessment difficult, and the subjective nature of identifying symptoms makes the current NCD dangerous. It is well-established, regardless of disease, and across all spectrums of care, that early intervention improves outcomes and reduces cost.

Evidence Summary

Multiple randomized trials demonstrate that early intervention in asymptomatic severe AS improves survival, reduces heart failure hospitalizations, and prevents sudden cardiac death. Key findings include:

• AVATAR Trial: Early AVR in asymptomatic severe AS reduced the composite endpoint of death, MI, stroke, or unplanned hospitalization.
• EARLY TAVR Trial: TAVR in asymptomatic severe AS significantly reduced death, stroke, and unplanned cardiovascular hospitalization compared with surveillance, with excellent safety and quality of life outcomes.
• TVT Registry: The majority of TAVR procedures are done electively. Patients that deteriorate quickly must have their procedure done urgently or emergently. Registry data confirms these patients have significantly higher rates of mortality and stroke as compared to their elective counterparts.

Rationale for NCD Update

Restricting coverage to symptomatic patients delays treatment until irreversible myocardial damage occurs. Updating the NCD to include asymptomatic severe AS would:

• Prevent avoidable mortality and improve outcomes
• Reduce heart failure admissions
• Decrease the total cost of care
• Align Medicare coverage with contemporary evidence

2. Sunset the Coverage with Evidence Development (CED) Requirement

Evidence Summary

The CED requirement was appropriate during the early adoption phase of TAVR, when products were still in their infancy, and safety and effectiveness had not yet been established. However, more than a decade of data—including randomized trials, FDA post market studies, and the STS/ACC TVT Registry—has confirmed consistent improvements in mortality and complication rates in conjunction with the continued evolution of products and clinical experience.

• Over 1 million TAVR procedures have been performed worldwide.
• Outcomes for low, intermediate, and high-risk patients are well characterized.
• Device durability now exceeds 8–10 years with excellent hemodynamic performance.

Rationale for NCD Update

The safety and effectiveness of TAVR is unequivocally established, and the CED requirement no longer provides incremental value, and imposes an additional administrative and cost burden on hospitals. Without this requirement in place, facilities would be free to continue to elect to participate in the registry, or monitor quality and outcomes data through other processes and systems.

3. Eliminate Volume Requirements

The original volume thresholds were intended to ensure procedural safety during the early learning curve and procedural uncertainty. In contemporary practice, these requirements restrict capable facilities and operators from offering TAVR to their patients. This has particular impact to rural and underserved populations, and forces patients to travel long distances despite equivalent local expertise.

Evidence Summary

Contemporary data show:

• No correlation between institutional AVR/PCI volume and TAVR outcomes in the modern era.
• Operator and team experience, not historical surgical volume, is the primary determinant of outcomes.
• Many low volume centers achieve outcomes equivalent to or better than high volume centers due to standardized protocols, proctoring, and improved device technology.

Rationale for NCD Update

Removing volume requirements would:

• Expand equitable access
• Reflect contemporary evidence
• Allow hospitals to build TAVR programs based on quality, not legacy surgical volume, or declining PCI volumes - especially important for rural and community centers

4. Remove Outdated Staffing Requirements

The requirement for two cardiothoracic surgeons, dual consults, and co surgeon participation was appropriate when TAVR was new and high risk. In contemporary practice, this requirement creates a staffing and efficiency burden, contributes to the approximate 6 month wait patients must endure from diagnosis to treatment, and does not correlate with improved outcomes.

Evidence Summary

• TAVR is routinely performed without surgical cut down, and conversion to open surgery is exceedingly rare (<0.3%) according to TVT Registry data, reducing the need for surgical backup
• According to the ACC and AHA, cardiovascular disease prevalence continues to increase, and the number of cardiologists and surgeons is expected to continue to decline. These trends, an aging population, and the current requirements create a potential tsunami for increasing delays in care and worsening patient outcomes.

Rationale for NCD Update

CMS should modernize staffing requirements to reflect current practice and the need to deliver more efficient care by:

• Allowing flexible heart team models without rigid staffing mandates. This is especially important to those rural centers who have difficulty maintaining 2 cardiothoracic surgeons on staff, requiring programs to shut down and closing access to patients
• Removing the co surgeon requirement. This will allow for more efficient delivery of care, reduce patient wait times, and increase facility procedural capacity
• Allowing consults based on clinical need, not regulation. The current requirements contribute to patients being subjected to upwards of 7 different visits prior to procedure, significantly delaying treatment

Conclusion

The TAVR landscape has transformed dramatically since the current NCD was established. The evidence now supports:

• Early intervention in asymptomatic severe AS
• Retirement of the CED requirement
• Removal of outdated volume thresholds
• Modernization of staffing requirements

Updating the NCD will ensure that Medicare beneficiaries receive timely, evidence based, and equitable access to life saving therapy. I respectfully urge CMS to update the TAVR NCD to align coverage with contemporary science, clinical practice, and patient needs.

Thank you.

Less

I am an interventional and structural cardiologist with many years of experience in TAVR procedure. TAVR is an established safe, effective and life saving procedure in low, intermediate and high risk surgical patients. ( Partner I, II and III trials). There is also growing evidence that supports TAVR in asymptomatic patients with severe aortic stenosis. (Early TAVR Trial).

Despite these advances, there remains significant delay in delivering this procedure to a significant number of patients due to current NCD/CMS mandates and requirements. Although the presence of a cardiothoracic was necessary during the initial adoption of the procedure, the procedure has matured enough and the presence of cardiothoracic surgeon during the initial evaluation of the patient and during the actual procedure is totally unnecessary. TAVR has undergone significant evolution in device technology, operator experience and techniques and it can be done safely by single experienced operator similar to performing percutenous coronary intervention.

I urge CMS to revise the current NCD 20.32 in a way that protects quality and facilities the delivery of care to patient with severe aortic stenosis bu:

1. Cover appropriate asymptomatic severe aortic stenosis patients
2. Remove outdated requirements that delay care.

Thank you for the opportunity to comment and for the CMS commitment for improving patient care and coverage.

Less

January 11, 2026

Mehmet Oz, MD
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: CAG-00430R2 – National Coverage Determination Reconsideration for Transcatheter Aortic Valve Replacement

Dear Dr. Oz,

Pi-Cardia appreciates the opportunity to comment on CMS’s reconsideration of the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). As TAVR continues to mature and expand across patient populations, we support CMS’s efforts to reassess coverage in light of evolving clinical evidence, advancing technologies, and increasing procedural complexity shaping contemporary care needs, particularly for patients requiring more advanced planning and risk mitigation.

About Pi-Cardia and ShortCut
Pi-Cardia is a global leader in the development of non-implant, catheter-based solutions for the treatment of structural heart disease. Our flagship technology, ShortCut™, is a concomitant, catheter-based system designed to split valve leaflets of a pre-existing valve prior to TAVR in patients at risk for coronary obstruction. ShortCut is FDA-approved and supported by prospective clinical evidence demonstrating safety and procedural effectiveness in appropriately selected patients (Dvir et al., 2024).

Pi-Cardia has a particular focus on developing solutions for complex TAVR patients, such as valve-in-valve candidates and anatomically high-risk cases, where procedural planning, multidisciplinary collaboration, and adjunctive technologies are central to achieving safe outcomes.

Evolution of TAVR and Implications for Policy
Over the past decade, TAVR has matured into a widely adopted standard of care. Reflecting this evolution, TAVR has become the preferred treatment for aortic stenosis and has recently surpassed surgical aortic valve replacement even among patients younger than 65 years of age (O’Riordan, 2024). As a result, an increasing number of younger patients are now receiving bioprosthetic valves and are expected to require future reintervention as these valves degenerate over time.

These trends underscore the importance of coverage policies that reflect contemporary practice patterns, longer patient lifespans, and thoughtful lifetime management strategies. Importantly, the maturation of TAVR has not resulted in uniform simplicity across all patients; rather, it has expanded the breadth and complexity of clinical scenarios encountered in contemporary clinical practice.

Procedural Heterogeneity and Complex Patient Populations
As access to TAVR expands to earlier-stage heart valve disease patients and broader clinical profiles, the procedural landscape has become increasingly heterogeneous. While many procedures today are relatively straightforward, a meaningful subset of patients presents with increased procedural complexity. These include patients with challenging anatomy or valve morphology, heavy calcification, prior bioprosthetic valves, or other structural features that heighten procedural risk and require proactive, individualized planning, often informed by collaborative, multidisciplinary input.

As TAVR becomes more commonplace, this divergence between routine and complex cases has become more pronounced. Complex patients may require greater operator expertise, more sophisticated procedural approaches, and access to adjunctive technologies, and may be less well served under care pathways designed primarily for routine interventions.

Within this growing complex cohort, certain risks further contribute to procedural challenges. Coronary obstruction, while uncommon, remains a serious complication of TAVR, particularly in valve-in-valve procedures and in patients with challenging anatomies. As valve-in-valve volumes increase, this risk is expected to contribute to growing procedural complexity and the need for careful pre-procedural planning and risk mitigation (Khan et al., 2021).

Role of Enabling Technologies in Contemporary TAVR Care
In response to the growing complexity of TAVR cases, safe and effective treatment increasingly depends not only on the valve platform itself, but also on the availability of advanced, adjunctive transcatheter technologies that enable careful planning and risk mitigation in complex scenarios.

Prospective clinical data support the role of leaflet modification technologies in this setting. The ShortCut pivotal study demonstrated that pre-emptive leaflet modification can be performed safely and efficiently in patients undergoing TAVR who are deemed at risk for coronary obstruction (Dvir et al., 2024). These data illustrate how innovation can support the safe treatment of complex patients when applied selectively and guided by appropriate clinical judgment.

As valve-in-valve procedures become more common, the need for strategies that preserve coronary access and mitigate procedural risk is expected to increase. More than 42,000 valve-in-valve TAVR procedures are projected to be performed annually in the United States by 2035, representing over 15 percent of all TAVR procedures (Généreux et al., 2025). This anticipated growth further reinforces the importance of operator experience, careful case planning, and access to supporting technologies to maintain patient safety and outcomes.

Patient-Centered Care and Shared Decision-Making
We believe future coverage considerations would benefit from a holistic view of the TAVR ecosystem that reflects both the maturity of the core therapy and the full spectrum of patient complexity encountered in contemporary clinical practice. Supporting appropriate access to enabling technologies respects physician judgment, promotes equitable patient access, and aligns policy with how care is delivered across diverse patient populations.

Importantly, innovations such as ShortCut are intended to support clinicians and patients in navigating procedural complexity, not to replace clinical judgment or established care pathways. Coverage frameworks that recognize evolving evidence and emerging technologies can help ensure that patients, in partnership with their multidisciplinary care teams, are able to consider appropriate treatment options aligned with their unique clinical and anatomical needs, risk tolerance, priorities, and values.

Closing
Pi-Cardia supports CMS’s reconsideration of the TAVR NCD and appreciates CMS’s leadership in evaluating how coverage policies can best reflect contemporary clinical practice. We thank CMS for the opportunity to share these perspectives and welcome continued engagement as the reconsideration process moves forward.

Respectfully,

Erez Golan
Founder & CEO
Pi-Cardia, Inc.

References
1. Dvir D, Tchétché D, Leon MB, et al. Leaflet modification before transcatheter aortic valve implantation in patients at risk for coronary obstruction: the ShortCut study. Eur Heart J. 2024;45(33):3031-3041. doi:10.1093/eurheartj/ehae303
2. O’Riordan M. National data point to soaring TAVI rates in patients under 65. TCTMD. Published June 14, 2024.
3. Khan JM, Babaliaros VC, Greenbaum AB, et al. Preventing coronary obstruction during transcatheter aortic valve replacement: results from the multicenter international BASILICA registry. JACC Cardiovasc Interv. 2021;14(9):941-948. doi:10.1016/j.jcin.2021.02.035
4. Généreux P, Leon MB, Dar RD, et al. Predicting Treatment of Bioprosthetic Aortic Valve Failure in the United States: A Proposed Model. Structural Heart. 2025;9(2):100339. doi:10.1016/j.shj.2024.100339.

Less

As one of the original Medtronic CoreValve TAVR investigators, I have worked with both Medtronic and CMS and physicians and institutions around the country for the past 15 years. I would like to comment on the upcoming NCD reconsideration of coverage for transcatheter valves.
Medicare coverage has in part enabled physicians and institutions to provide high-quality structural heart care for over a decade. The concept of heart team involvement was groundbreaking at the time, but has become a key foundation, allowing multidisciplinary decision-making to take place between various specialists, especially cardiologists and cardiac surgeons. That heart team concept works as it is patient centric care provided by the TAVR team. It is essential that we continue participation in the STS/ACC. TVT registry in order to collect rigorous data which allows us to better care for patients across the entire spectrum of our care. Additional program requirements are necessary so that physicians and hospitals/systems meet standards based on guideline based care and a clear clinical consensus that is data driven. The existing TAVR NCD has worked and successfully promoted quality care and patient access. Any potential changes must follow the above successful recommendations as well as advance patient care with data proving outcomes with enhanced access to underserved populations. They must also maintain quality and data collection as new technology is developed and becomes available.

In summary keeping the successful NCD requirements intact and making changes which would only advance the successful program that has been in place for over a decade is critical for us to continue successfully treating patients with advanced therapies like TAVR. Thank you.

Less

Dear CMS,
I appreciate the opportunity to comment on CMS’s proposed updates to Medicare coverage for transcatheter aortic valve replacement (TAVR). I submit these comments in support of CMS’s stated goals to improve patent (beneficiary) access, reduce unnecessary delays and burden, preserve patient safety and outcomes, and steward limited healthcare resources responsibly.
Based on contemporary evidence and daily clinical experience, several longstanding TAVR coverage requirements no longer reflect current practice or data and may inadvertently limit access to timely, high-quality care for Medicare beneficiaries.

I respectfully offer the following recommendations:

1. Eliminate the mandatory Co-Scrub Requirement for a Cardiac Surgeon.
The requirement for a cardiac surgeon to physically co-scrub for all TAVR procedures no longer reflects contemporary evidence or procedural realities. Conversion to open surgery during TAVR is now exceedingly rare, with contemporary registry and trial data demonstrating conversion rates well below 1% and lower than other cath lab procedures. Moreover, when acute complications occur – such as coronary occlusion, valve embolization, pericardial tamponade – these events are most commonly managed successfully using percutaneous techniques rather than open surgery. In such crisis situation, it is more useful to have someone with formal deep knowledge of catheters, wires, balloons who can rapidly assist.
Clinical outcomes in TAVR have improved dramatically over time, driven primarily by advances in device design, procedural standardization, imaging and patient selection – not by the routine physical presence of a surgeon in the catheterization laboratory. Eliminating the mandatory co-scrub requirement would improve access, reduce procedural delays, and allow more efficient use of scarce surgical resources without compromising patient safety.
This change would benefit all centers across the country, small or large, urban or rural centers but more importantly disproportionately benefit rural and resource-limited centers, where surgeon availability may be a primary barrier to timely care.

2. Remove the Mandatory Two-Physician Pre-Procedure Evaluation Requirement. The requirement to two independent physician evaluation prior to TAVR frequently introduces unnecessary delays, additional co-pays, transportation challenges, and caregiver burden for elderly and mobility-limited beneficiaries. In the modern heart-team based practice, treatment decisions are already multidisciplinary and longitudinal, with referring cardiologists, interventional cardiologists, imaging specialists, and surgeons engaged throughout the patient’s course.
Forcing duplicative clinic visits does not add meaningful incremental value in most cases and commonly delays definitive treatment of symptomatic patients with severe aortic stenosis – an approach that is not benign given the progressive and life-threatening nature of the disease. Streamlining this requirement would reduce beneficiary burden and align Medicare policy with real-world, team based clinical decision making.

3. Streamline Registry Data requirements / Participation. Frailty assessment and Kansas City Cardiomyopathy Questionnaire (KCCQ) data collection were initially valuable during early adoption during early TAVR. However, in contemporary practice, these provide limited incremental value. Healthcare systems are resource constrained and streamlining or targeting these data requirements would allow clinical teams to redirect resources toward direct patient care while maintaining quality oversight. Self-reported data based registries add little value when we have well done prospective core lab adjudicated randomized clinical trials.

4. Expand Coverage to Selected Asymptomatic Patients with Severe Aortic Stenosis. Emerging randomized trial data (EARLY TAVR, AVATAR, EVOLVED) increasingly Support earlier intervention in selected asymptomatic patents with severe aortic stenosis. Surgical aortic valve replacement (SAVR) has historically been permitted in asymptomatic patients based on disease severity and risk stratification, yet TAVR coverage remains more restrictive despite comparable – an in many cases superior – outcomes in contemporary trials.

Conclusion
CMS’s willingness to re-examine TAVR coverage criteria is commendable. Updating these requirements to reflect contemporary evidence and practice would mean meaningfully improve patient access, reduce unnecessary delays and burden, preserve excellent outcomes, and ensure responsible use of healthcare resources. Thank you for the opportunity to provide these comments and we look forward to decision.

Less

A key area of opportunity for patients with Severe Aortic Stenosis is timely access to procedural care for those in which intervention is indicated. A recent study, the EARLY TAVR trial, outlined superiority of access to procedure versus watchful waiting. In many of our healthcare organizations we have had challenges of access to care - longer than desired wait times for TAVR which delay care and jeopardize optimal patient outcomes - both mortality and QALY. Although the EARLY-TAVR trial focuses on watchful waiting - these same benefits of early TAVR for patients as identified indications for TAVR is important. Access to care and procedure wait times are challenging in many organizations. Below is an excerpt from the recent EARLY TAVR trial results.

A total of 901 patients were randomized, with 455 undergoing TAVR and 446 assigned to clinical surveillance. The composite primary endpoint, including death from any cause, stroke, or unplanned hospitalization for CV causes, occurred in 122 patients (26.8%) in the TAVR group compared with 202 patients (45.3%) in the clinical surveillance group (HR, 0.50, [95% CI, 0.40–0.63], p < 0.001). Moreover, this was mainly driven by a benefit in the TAVR group regarding unplanned hospitalization (20.9% vs. 41.7%, HR, 0.43, [95% CI, 0.33–0.55]), with no significant differences in death from any cause (8.4 vs. 9.2 HR, 0.93, [95% CI,0.60–1.44]), and stroke (4.2% vs. 6.7%, HR, 0.62, [95% CI, 0.35–1.10]).

Regarding the secondary endpoint, a favorable outcome at 2 years occurred in 86.6% of patients in the TAVR group and 68.0% of patients in the clinical surveillance group (p < 0.001). Integrated LV and LA measures 2 years occurred in 48.1% and 35.9% of patients, respectively (p < 0.001). Among the 446 patients randomly assigned to clinical surveillance, 388 (87.0%) underwent AVR during follow-up, with the median time from randomization to conversion to AVR being 11.1 months (IQR, 5.0–19.7). In contrast to The EVOLVED Randomized trial, The EARLY TAVR trial demonstrated that early TAVR was superior to clinical surveillance regarding the primary composite end point and secondary endpoints. The percentage of mortality appeared to be similar in both groups but was lower than in previous trials, which can be explained by the less invasive nature of TAVR compared to surgery.

Khedr AE, Odeh NB, Bcharah G, Abdalla HM, Senjab A, Zeineddine RM, Ram J, Farina JM, Crystal OR, Barrus B, Lester SJ, Shipman J, Alsidawi S, Ayoub C, Sell-Dottin KA, Arsanjani R. Comparing Early Intervention to Watchful Waiting: A Review on Risk Stratification and Management in Asymptomatic Aortic Stenosis. Medicina (Kaunas). 2025 Mar 4;61(3):448. doi: 10.3390/medicina61030448. PMID: 40142259; PMCID: PMC11943529.

As a healthcare administrator, the ability to provide appropriate care in a timely fashion is imperative and something I feel responsible for. As we look at TAVR and the current requirements (NCD), it is challenging operationally to assure timeliness due to the required resources and economic challenges. We have learned much over the last 15 years of TAVR care and have shown optimal outcomes that have allowed us to evolve our delivery model to lower costs - adjustments to staffing, site of care (OR vs Cath Lab), LOS, and patient throughput. Taking the opportunity to review the current NCD and continue to evolve regulatory requirements based on what we have learned over the last 15 years is prudent. I'm thankful for a healthcare system that seeks to evolve as our evidence supports a change in care delivery while maintaining optimal outcomes for our patients.

Less

I strongly support CMS’s effort to modernize coverage criteria for structural heart procedures. However, I urge CMS to reconsider the strict requirement for an interventional cardiologist and a cardiac surgeon to be present as co-operators for procedures such as TAVR.

Current evidence shows that surgical conversion during transcatheter structural procedures is extremely rare and is comparable to emergent conversion rates seen in other widely accepted interventions (e.g., PCI), where a surgeon is not required to be physically present. Moreover, advances in technology, imaging, and procedural techniques have significantly improved safety and outcomes, making rigid co-operator mandates outdated.

While I agree that two operators with the appropriate expertise should be involved in these procedures to optimize outcomes and safety, the requirement should be based on competency and training in structural heart interventions, rather than by specialty title. Specifically, I recommend that CMS revise the language to require:

Two Structural Heart–Trained Operators (e.g., interventional cardiologists or cardiac surgeons with documented structural heart procedural competency), irrespective of one being an interventional cardiologist and the other a surgeon.

This approach would better reflect modern practice, reduce unnecessary barriers to access caused by scheduling and staffing constraints, and focus on the qualifications that actually matter for patient safety and procedural success.

Less

- TAVR for asymptomatic severe AS should be considered as we have clearly
Seen poor outcomes with watchful waiting, as there are no known medical therapies that would modify the valvular disease process
- role of heart team/surgical presence/input needs to be revisited. In the current scenario, TAVR is mostly performed as an interventional procedure with very rare instances of needing surgical bailout, similar to PCI/LAAO related complication. As long as hospital has a measure to have surgical backup, it should be regarded as an interventional procedure, and it does not make sense that the revenue units from this procedure are split half and half even though most of the work/liability is on the performing Interventionalist. The referencing cardiologist does not claim half RVUs for every SAVR/CABG that is performed.

Less

As an implanting physician since 2012, I believe that the TAVR procedure has matured and an update to the NCD is appropriate. I believe that the requirements for NCD reporting should be streamlined to reduce the burden of this requirement on administrative staff. I think NCD should extend to asymptomatic patients with severe, (D1) aortic stenosis and that the pre-procedure requirements should be brought up to current evidence based practice. I would be in favor of reducing some of the facility and physician requirements for TAVR but still support a minimum number of aortic surgeries and coronary interventions and would keep the requirements for a Heart Team discussion and would make this requirement more flexible to conform with routine practice and communication between physicians on the Heart team.
Thank you for working to improve access for our patients to this life changing procedure.
Alphonse M Ambrosia, DO
Interventional Cardiologist

Less

I appreciate CMS’s reconsideration of the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR). I support revisions that align coverage with current evidence, contemporary clinical practice, and a competency- and outcomes-based approach to quality oversight.

SUMMARY OF RECOMMENDED REVISIONS

CMS should consider revisions that:

1. Update covered indications to align with FDA labeling where applicable and the totality of evidence, including appropriately selected patients with severe aortic stenosis who are asymptomatic (where included in FDA labeling).
2. Limit Coverage with Evidence Development (CED) to narrow new indications where CMS determines additional evidence is needed for Medicare beneficiaries.
3. Revise structural and workflow requirements that are overly prescriptive and may delay care without demonstrated benefit, while retaining program safeguards tied to safe delivery of care.

Because Medicare coverage is limited to items and services that are reasonable and necessary, coverage conditions should be no more restrictive than needed to ensure safe and effective care, while supporting timely access for beneficiaries.

I. COVERED INDICATIONS

CMS should consider updating covered indications to align with FDA labeling where applicable and the totality of evidence. In particular, if FDA labeling includes appropriately selected patients with severe aortic stenosis who are asymptomatic, coverage should be structured to allow access for those beneficiaries under appropriate program safeguards and documentation requirements.

II. COVERAGE WITH EVIDENCE DEVELOPMENT (CED)

Given the extensive randomized trial evidence and mature real-world outcomes data for established, FDA-labeled indications, CMS could rely on operator and program qualification requirements and outcomes-based quality oversight rather than broad CED requirements. CED could be reserved for narrow new indications where evidence is evolving or where CMS determines that additional post-market evidence is needed to confirm outcomes in Medicare beneficiaries.

Consistent with CMS’s CED guidance, CED should be reserved for situations where less restrictive coverage is not justified by available evidence, and where evidence generation can address specific evidentiary uncertainties relevant to Medicare beneficiaries.

III. HEART TEAM EVALUATION AND DOCUMENTATION

A. Heart Team structure and workflows

Multidisciplinary Heart Team evaluation and shared decision-making remain foundational to safe, high-quality TAVR care and should continue to be required and documented in the medical record. However, the NCD should avoid overly prescriptive requirements regarding Heart Team composition and workflows, and should allow programs flexibility to organize roles and processes based on local resources, expertise, and patient needs.

B. Heart Team discussion and patient evaluation requirements

CMS should recognize that a documented multidisciplinary Heart Team case review (e.g., a Heart Team case conference or equivalent structured review) can appropriately satisfy the Heart Team discussion requirement when it includes review of clinical history, imaging, procedural risk, and treatment alternatives.

A uniform requirement for independent in-person evaluation by multiple specialties for every patient is unnecessarily prescriptive and may delay care, increase cost, and add administrative burden without clear evidence of improved outcomes. Instead, the NCD could specify that in-person consultation by additional specialties should be performed when clinically indicated. This preserves multidisciplinary decision-making and patient-centered care while allowing practical, efficient workflows that support timely access.

IV. PROCEDURAL STAFFING REQUIREMENT

CMS should consider revising the NCD to remove a requirement that each TAVR procedure be performed jointly by an interventional cardiologist and a cardiac surgeon as co-operators in every case. A fixed specialty co-operator requirement may create avoidable operational barriers (including scheduling constraints and delayed access), without demonstrated benefit beyond what is achieved through operator experience, institutional capability, and program-level quality oversight.

On-site cardiac surgery services, appropriate infrastructure, and established escalation pathways provide an appropriate safety framework without requiring surgeon co-operator participation in every case.

CMS has taken an approach in other complex structural heart NCDs that defines a single qualified procedure operator by specialty and experience rather than requiring a fixed co-operator model for every procedure. In particular, NCD 20.33 (Transcatheter Edge-to-Edge Repair [TEER]) and NCD 20.34 (Percutaneous Left Atrial Appendage Closure [LAAC]) establish specialty- and training-based operator requirements and program safeguards without mandating a uniform multi-specialty co-operator pairing for each case. A similar approach for TAVR would improve consistency across structural heart NCDs while maintaining patient protections.

Accordingly, CMS should permit TAVR to be performed by a single qualified operator who is either an interventional cardiologist or a cardiac surgeon within a qualified Heart Team program, based on local program structure and patient needs, provided all facility and program requirements are met. Doing so would improve timely access to care without jeopardizing quality of care.

V. PROGRAM REQUIREMENTS: SAFEGUARDS, QUALITY OVERSIGHT, AND VOLUME

These recommendations are not intended to reduce oversight or safety standards. The NCD should continue to require program-level safeguards directly tied to safe delivery of care, including:

• Hospital capability requirements, including on-site cardiac surgery services and appropriate infrastructure
• Operator and program qualification standards (training, experience, and demonstrated performance)
• Participation in a quality assessment program with outcomes monitoring, benchmarking, periodic review, and performance improvement processes
• Minimum program volume requirements as a pragmatic proxy for maintaining procedural experience and program capability, consistent with contemporary registry evidence demonstrating a relationship between procedural volume and outcomes

CMS should allow flexibility in the quality assessment mechanism by permitting participation in a local, regional, or national quality assessment program, provided it includes systematic outcomes tracking, benchmarking, periodic review, and processes for performance improvement. This flexibility would better align with local needs while preserving accountability.

VI. RECOMMENDED COVERAGE LANGUAGE (suggested for CMS consideration)

Heart Team discussion and evaluation

“Coverage requires documentation of a multidisciplinary Heart Team case review and shared decision-making process. This requirement may be satisfied through a local multidisciplinary conference or equivalent structured review of the clinical record and diagnostic testing. Independent in-person evaluation by specific specialties is not required in every case and should be performed when clinically indicated.”

Operator requirement

“TAVR is covered when performed by a qualified operator who is either an interventional cardiologist or a cardiac surgeon within the Heart Team, based on local program structure and patient needs, provided the operator meets applicable qualification requirements and the procedure is performed in a hospital with on-site cardiac surgery services and appropriate infrastructure.”

Quality assessment program

“Facilities must participate in a quality assessment program with outcomes monitoring and benchmarking. The quality assessment program may be local, regional, or national, provided it includes systematic outcomes tracking, benchmarking, periodic review, and processes for performance improvement.”

Minimum volume requirements

“Facilities must meet minimum program volume requirements to maintain procedural experience and program capability.”

CONCLUSION

CMS should consider revising the TAVR NCD to emphasize competency- and outcomes-based oversight rather than prescriptive workflow and procedural staffing requirements. Allowing documented multidisciplinary case review to satisfy the Heart Team discussion requirement, permitting TAVR to be performed by a single qualified operator (interventional cardiologist or cardiac surgeon) within a qualified Heart Team program, limiting CED to narrow new indications, and maintaining program safeguards (including minimum volume requirements and participation in a quality assessment program) would preserve patient safety while reducing unnecessary barriers to timely care for Medicare beneficiaries.

Less

I appreciate the opportunity to comment on the reconsideration of the National Coverage Determination for TAVR.

1. Since its initial adoption, TAVR has advanced considerably, with substantial improvements in device technology, procedural safety, operator experience, and long-term outcomes. An expanding body of evidence supports the benefit of earlier intervention in carefully selected patients with asymptomatic severe aortic stenosis. Restricting coverage to symptomatic patients alone may unnecessarily delay definitive treatment and expose some patients to preventable adverse outcomes.

2. The multidisciplinary Heart Team approach has been central to the success of TAVR and should continue to be strongly encouraged to support thoughtful patient selection and shared decision-making. While some institutions benefit from robust surgical support, this is not universally the case across TAVR-performing hospitals nationwide. A mandatory in-person surgical evaluation for every patient before TAVR results in significant delays to care in many areas. Allowing programs flexibility to determine the most efficient and safe workflow—while preserving meaningful multidisciplinary input—would improve access without compromising quality.

3. Similarly, the requirement for two operators for every TAVR procedure no longer reflects contemporary safety data or clinical practice. A more flexible, program-level approach would allow institutions to tailor procedural staffing (single versus two operators) and procedural setting (catheterization laboratory versus hybrid operating room) based on operator experience, patient complexity, and local outcomes. Importantly, on-site surgical backup should remain a requirement to ensure patient safety in the rare event of a serious complication.

Thank you for your consideration.

Less

I appreciate the opportunity to comment on CMS’s proposed updates to National Coverage Determination (NCD) requirements for Transcatheter Aortic Valve Replacement (TAVR), including continued participation in the National Cardiovascular Data Registry (NCDR) and structural care team requirements.

While I support data-driven quality improvement, current policies are producing unintended consequences that restrict access to life-saving therapy for the highest-risk Medicare beneficiaries. My comments address: (1) treatment of asymptomatic severe aortic stenosis (AS), (2) mandatory surgeon visits, and (3) mandatory participation in the TVT Registry, with particular emphasis on recently published evidence demonstrating harm to high-risk patients.

?

1. Support for Treating Asymptomatic Severe Aortic Stenosis

Contemporary randomized evidence supports early intervention in selected patients with asymptomatic severe AS. The EARLY TAVR trial demonstrated a significant reduction in death, stroke, and unplanned cardiovascular hospitalization with early TAVR compared with clinical surveillance. These findings are consistent with prior surgical trials (e.g., AVATAR), which showed improved survival and reduced heart failure events with early valve replacement.

Asymptomatic severe AS is not benign. Delayed intervention risks sudden cardiac death, irreversible myocardial remodeling, and heart failure progression. CMS coverage policy should evolve in alignment with current evidence and permit coverage for appropriately selected asymptomatic patients based on shared decision-making and Heart Team assessment.

?

2. Opposition to Mandatory In-Person Surgeon Visits

There is no evidence that a mandatory in-person visit with a cardiac surgeon improves outcomes for patients clearly appropriate for transfemoral TAVR. Modern Heart Team care is routinely delivered through multidisciplinary conferences, imaging review, and shared documentation, including virtual participation when appropriate.

Mandatory surgeon visits create barriers to timely care, particularly for frail, elderly, rural, and mobility-limited patients, without demonstrable quality benefit. CMS should allow flexibility in documenting Heart Team collaboration rather than enforcing rigid structural requirements that delay care.

?

3. Opposition to Continued Mandatory Participation in the TVT Registry

Recent peer-reviewed evidence now clearly demonstrates that mandatory registry participation and public reporting are associated with declining access to TAVR for high-risk patients.

a. Documented Decline in High-Risk TAVR Treatment
A recently published national analysis (2024–2025) evaluating U.S. hospitals performing TAVR found a significant decline in the number of high-risk patients undergoing TAVR over time, particularly at hospitals subject to public performance ratings. Centers with lower publicly reported TAVR ratings experienced a marked reduction in high-risk case volume, with an incidence rate ratio of approximately 0.56, indicating that these hospitals treated nearly half as many high-risk patients compared with prior periods.

Importantly, the authors concluded that this decline was not explained by changes in disease prevalence or procedural appropriateness, but was instead consistent with risk-averse behavior driven by public reporting and performance metrics.

b. Relationship to Star Ratings and Public Quality Metrics
TVT Registry data are directly or indirectly incorporated into hospital quality assessments and CMS Star Ratings, which carry significant reputational and financial consequences. These metrics inadequately adjust for extreme patient risk, frailty, cardiogenic shock, and social complexity—features that define many Medicare TAVR candidates.

As a result, hospitals face strong incentives to avoid offering TAVR to the sickest patients, even when the procedure represents the only meaningful therapeutic option. This dynamic penalizes centers that care for vulnerable populations and undermines CMS’s stated goals of equity and patient-centered care.

c. Registry Data Trends Suggest Risk Selection Rather Than Quality Improvement
Additional analyses of TVT Registry data from recent years demonstrate that while unadjusted short-term outcomes appear stable, risk-adjusted mortality has increased over time. This paradox suggests increasing patient selection and avoidance of the highest-risk cases, rather than true deterioration in procedural quality.

After more than a decade of mandatory participation, there is no evidence that compulsory TVT Registry enrollment improves outcomes compared with alternative oversight mechanisms. Instead, it has produced substantial administrative burden and, more importantly, measurable restriction of access for high-risk patients.

?

Conclusion

The most recent evidence confirms what many clinicians observe daily: mandatory registry participation, public reporting, and downstream Star Ratings are contributing to risk aversion and denial of TAVR to patients who may benefit the most.

I respectfully urge CMS to:

1. Support coverage for TAVR in appropriately selected asymptomatic severe AS patients.
2. Eliminate mandatory in-person surgeon visit requirements while preserving Heart Team decision-making flexibility.
3. Reconsider mandatory TVT Registry participation as a condition of coverage, given its demonstrated association with reduced access to care for high-risk Medicare beneficiaries.

CMS policy should prioritize patient-centered outcomes and equitable access over structural and reporting requirements that unintentionally harm vulnerable populations.

Thank you for the opportunity to provide comment.
Respectfully,

Less

I appreciate CMS’s efforts to modernize the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR) in light of contemporary evidence and practice. I respectfully recommend revising the procedural staffing requirements to remove the mandate that each TAVR procedure be performed jointly by an interventional cardiologist and a cardiac surgeon, and instead allow programs flexibility to designate two qualified operators of their choosing.

While multidisciplinary Heart Team collaboration remains foundational to high-quality structural heart care, mandating a fixed specialty pairing at the time of every procedure is unnecessarily prescriptive and is not supported by evidence demonstrating superior outcomes. Patient outcomes in contemporary TAVR programs are driven primarily by operator experience, institutional infrastructure, and system-level quality oversight, rather than by rigid procedural co-operator composition.

Importantly, CMS has already adopted a flexible, competency-based operator framework for other complex structural heart interventions. Under the National Coverage Determination for transcatheter edge-to-edge repair (TEER), CMS permits procedures to be performed by an interventional cardiologist or a cardiac surgeon, provided institutional requirements and surgical backup are met. Aligning TAVR operator language with this established CMS precedent would promote internal consistency across structural heart coverage policies while preserving patient safety.

Requiring a specific interventional cardiologist–surgeon procedural pairing can also negatively affect patient access and operational resilience, particularly in smaller, rural, or high-volume programs where scheduling constraints may delay care for patients with a time-sensitive condition. Coverage policy should avoid creating preventable access barriers when equivalent quality and safety can be achieved through program-level standards and outcomes monitoring.

I emphasize that this recommendation does not propose weakening quality safeguards. Programs should continue to meet all institutional requirements, including:

• Multidisciplinary Heart Team evaluation and documentation,
• On-site cardiac surgery availability,
• Participation in registries and ongoing outcomes assessment (nationally or locally).

These program-level requirements appropriately safeguard quality and safety, whereas a rigid case-level co-operator mandate does not meaningfully add protection.

To support clarity and implementation, I respectfully propose the following replacement language for the procedural staffing requirement:

“TAVR must be performed by two qualified operators designated by the Heart Team, who may include an interventional cardiologist and/or a cardiac surgeon, based on local program structure and patient needs. The procedure must be performed in a hospital with on-site cardiac surgery services and appropriate infrastructure.”

This approach would allow sites to tailor physician staffing models based on local expertise and workforce realities, align TAVR policy with other CMS structural heart determinations, and focus coverage requirements on the factors most closely associated with patient outcomes.

I encourage CMS to adopt a competency- and outcomes-based framework rather than a prescriptive specialty pairing requirement, thereby modernizing the TAVR NCD to facilitate patient-centered access to care.

Less

The national coverage decision regarding TAVR should not be adjusted. The heart team concept to include cardiology and cardiac surgery independent evaluation of patients with aortic stenosis, ensures that the right procedure is chosen for the right patient. There is an increased utilization of TAVR in young (<65 yo), low risk patients. Many of these patients have bicuspid stenosis ad well. These were not the patient groups studied in the randomized trials for tavr. Removing the multispecialty evaluation and treatment will open the flood gates to a tavr first approach to all patients despite anatomy. Data suggest that there is an increased mortality in such patients treated with tavr. The NCD should remain as is to endure optimal patient outcomes.

Less

Having been part of the TAVR program as a CT surgeon for over a decade, I strongly see that the collaboration between the Surgeon and Structural Heart Specialist (Intervention Cardiologist) resulted in timely conduct of a safe TAVR procedure irrespective of patient's risk profile in over 1000 cases. Collaboration and joint delivery of an expert procedure is the cornerstone of successful outcome in any procedure, including TAVR. If there are perceived notions that the collaboration and joint conduct of procedure is falling short of benchmark expectation, then obtain objective data to make the decision. Share that data with public and make changes as needed.

Less

I have been shocked by the ESC/EACTS 2025 VHD Guidelines particularly for the choice of treatment method of Aortic Stenosis introducing a cut off 70y with no new evidence (DEDICATE safety end point at 1 year was favourable to TAVI but main end point is at 5 y) and giving it a LOE A
They could have made a I C meaning that was the expert opinion of the TF members.
Michael Borger has certainly fought hard against this but the arm twisting I endured as Co Chair of the 2018 Myocardial Revasc Guidelines about left main recommendations based on EXCEL let me imagine he went through a similar situation.
Either you accept or the whole collaboration with ESC is gone. Difficult trade offs on your shoulders.
In 2018, we had Domenico Pagano as Secretary General, who together with EACTS Council decided to keep the collaboration with ESC and the Revascularization Guidelines got published. However EACTS withdraw support for the left main recommendations.

Are the 30-day real world outcomes for TAVR similar enough to those from the pivotal studies?
The problem is that ESC has decided that in view of the many available RCTs comparing TAVI and SAVR observational studies were NOT to be taken into consideration as they were prone to confounding by indication.
And so even when out of 12 large Registries (National Registries like GARY, Austrian,Danish, Italian etc) with some sort of multivariate or propensity score adjustment all indicate similar or higher mortality for TAVI at 5 years, the decision was these results are biased because TAVI patients in registries are older, have more co morbidities and statistical adjustment cannot compensate for unaccounted hidden variables. Fair enough. But are RCTs flawless?
Also as a reminder this is the first time this sort of evidence is excluded from ESC Guidelines which uses this sort of evidence in their other Guidelines and without simultaneous consideration of the limitations of RCTs (no formal methodology analysis by an independent group of epidemiologists)
A recent paper by Kirov H et al Thorac Cardiovasc Surg 2025;73:332–345 reports and I quote
"While registry data have been heavily criticized (mainly for the inherent selection bias) and even excluded from generating guideline recommendations (if randomized evidence is available, such as in the TAVI-SAVR comparisons), in 2024, heavy criticism on RCT data for their representative value has been voiced
Since RCTs usually suffer from severe selectivity due to often long lists of in- and exclusion criteria, the generalizability of RCT data to all comers has been questioned. An additional, new critical aspect appears, if one relates outcomes to predicted risks. Except for the NOTION trials, all 30-day outcomes in trials showed observed to expected (O/E) ratios for mortality below 1, suggesting that
trial outcomes are selected not only from a patient perspective but also from a technician perspective because the vast majority of“technicians” in the trials performed above average.
If we then consider that surgical outcomes from RCTs are much closer to the available results from the various registries (SAVR mortality: GARY77/DEDICATE at 1 year 8.8% vs. 6.2%, STS low-risk data/PARTNER 3: 7.1% vs 8.2%), than the TAVI outcomes (low-risk TAVI 1-year mortality: GARY/DEDICATE 10% vs 2.6% a new“technician-bias” emerges that appears to primarily affect the TAVI arms.
The ever-improving outcomes in the interventional arms of RCTs also stand in stark contrast to the 2024 published observation in the US (786 hospitals), where mortality increased in TAVI patients over the years, although predicted risks of TAVI patients has come down in the same time period.(JAMA Cardiology 2024;9;(12):1115-1123. doi:10.1001/jamacardio.2024.3453)
Thus, the generalizability of RCT results experiences another level of concern, the“technician bias,”

30 day real world outcomes are globally concordant. The issue is 5y SAVR mortality in Evolut LR is well above the STS benchmark as reported by Thourani with 42.000 STS patients matched to the 2 low risk trials exclusion/inclusion criteria Thourani V et al Ann Thorac Surg 2024;117:106-12)
Table 2 summarises important mortality data of STS matched cohort vs P3 and Evolut LR where you can see that Evolut LR has much higher mortality in SAVR arm at 4 y than Partner 3 at 5 y and STS benchmark population. This might be a reason why mortality curves do not cross like in P3 at 3 years

2. Has 10-year durability of the TAVR valves been established?

NOTION is the only 10 year published results The mean age is 79. Its findings do not apply to the 73-74 mean age of P3 and Evolut LR as degeneration is much dependent on age
It has included implantation of Mitroflow and Trifecta valves in 34%. These valves have been retired from the market because of durability issues that sparked after 6-7 years. The same happened to the Toronto stentless valve.
40% of patients received 19 mm and 21 mm prosthesis. Also it used a fixed trans-prosthetic gradient cut-off for SVD diagnosis that could have resulted in the overestimation of the rate of prosthesis deterioration. This is the most probable reason why severe SVD occurred in 1.5% and 10.0% (HR 0.2; 95% CI 0.04–0.7; P = .02) after TAVI and SAVR, respectively and there was an incredibly 28% rate of PPM and 28% of SVD in the SAVR arm. Please note that annular enlargement was not allowed and the the rate of PPM in a Finnish valve registry of 4097 patients who underwent SAVR showed a 7.2% severe PPM rate, using the same IEOA cut-off.

Is it justifiable to recommend with a IA class a therapy for which we have results that are shorter than the patient's life expectancy?
Is it acceptable to omit to recommend at least as IIa a validated therapy with >10 year durability results based on short term trade offs of avoidance of incision and shorter recovery time and non inferiority of death/stroke at 5 years?
Is it fair to exclude from the secondary endpoints events that are known to portend unfavourable long term consequences like mild or more valvular regurgitation and conduction disturbances like LBBB or pace maker? And what about higher Stroke rate as shown in the UK TAVI trial at 10 years?
Is it reasonable to exclude almost a dozen National Registry data showing identical results to the trials in the SAVR arm but much better results in the TAVI arms of RCTs than registries all pointing in the same direction?
Is it safe to unleash a population with life expectancy> known durability of the transcatheter valve with a mortality risk 3 x higher if a reoperation is required vs a surgical bioprosthesis? And limited data for valve in valve?
Yes it is. Because patients do not want surgery! And if we don’t comply they go next door.
OK. BUT is this in patients best interests? and are patients really informed of the whole short and long term trade offs and uncertainties?

It is critical to keep gathering data on a compulsory basis to the STS/ACC TVT Registry in order to be able to detect tendencies and late outcomes that do not show in RCTs which are a very selected group with many exclusion criteria. Real world information is crucial for devices just like for Pharma post marketing surveillance. Regarding TAVR in asymptomatic patients this is based on a single RCT (EARLY TAVR)as the others were small and had several limitations
EARLY TAVR was positive only due to increased unplanned hospitalisations which is expectable due to the fact that patients knew they had something in their valve: subtraction anxiety bias. Furthermore the trial should have a surgical arm and finally implanting a TAVR or SAVR is replacing a disease by another disease as articial valves are associated with a number of valve related complications: endocarditis, thrombosis embolism, valve thrombosis, stroke, structural degeneration with non negligible associated morbidity and mortality. To base reimbursement on a single RCT which has not shown any benefit in terms of mortality is inappropriate in my opinion.
What is important is to keep a tight follow up, eventually perform a stress test to unmask symptoms and as there are no issues with access in the US (like in Canada and Portugal) indication for valve replacement is promptly performed

Less

Based on recent data I agree with the decision to approve TAVR for asymptomatic patients. In my own personal experience this helps patients avoid urgent hospitalizations and adverse cardiac remodeling. I also agree with removing barriers to care. TAVR volumes have increased to the point where the precautionary safety measures inherent to the original NCD are now coming at the cost of worsened patient outcomes due to prolonged wait times for the procedure. The largest barrier to access is the requirement for a surgical co-operator. Surgery groups cannot keep up with increased TAVR volumes and lack of surgical availability is frequently the bottleneck to patient care. The TAVR procedure has become much safer since inception and the frequency of urgent surgical intervention is equivalent or even less than other cardiac procedure currently performed without immediate surgical backup (Watchman, PCI, Micro, TEER, etc.). Furthermore, emergent salvage cardiac surgery is rarely successful. Lastly, with the increasing use and comfort of interventional cardiologist with ECMO, emergent ECMO placement with transfer to the next available OR is a more practical backup plan for serious complications. I would also remove the requirement for a surgical consult. Many TAVR patients are elderly and co-morbid with TAVR clearly being their best option. Requiring a surgical consult is another barrier care that delays treatment. Programs should be allowed to create their own policies regarding which patients require a surgical consult. I do believe that hospitals performing TAVR should be required to have an on-site cardiac surgery program.

Less

I am an interventional cardiac surgeon in practice for >15 years and have published extensively on the topic of TAVR in peer-reviewed medical journals. Our center performs >500 TAVR annually and I have fortunately been part of a multidisciplinary heart team consisting of general cardiologists, interventional cardiologists, cardiac surgeons, cardiac imagers, heart failure specialists and allied health professionals, since the FDA approval of TAVR in 2012. I have personally seen the evolution of the TAVR technologies, indications and tremendous benefits to our patients, a majority of which are CMS Medicare beneficiaries. I have witnessed the ongoing improvement in outcomes and quality of patients undergoing TAVR at our institution and nationwide, due to the intact heart team decision-making, and ongoing ACC/STS TVT registry to track real-world outcomes and ensure that Medicare beneficiaries will have the quality care that they deserve across all TAVR centers in the US. These accomplishments of TAVR as a safe, effective procedure (>110,000 in the US annually) have been a testament of the initial NCD in 2012 and subsequent update in 2019. As TAVR indications and the number of centers performing this procedure expand, Edwards Lifesciences has now requested CMD to reopen the NCD to update to reflect the contemporary practice of TAVR, specifically on asymptomatic severe aortic stenosis (AS), and removing barriers on the CED to improve access to the therapy. I would like to provide my own perspective of this field and what the requested changes to NCD entails:

Point #1: Updates to the TAVR NCD are needed to include asymptomatic patients not addressed under the current policy

RESPONSE: While we acknowledge that the evidence on the benefit of treatment of asymptomatic severe AS with aortic valve replacement (AVR) has increased since the last NCD, most available data currently supports the use of surgical AVR (SAVR) rather than TAVR in this patient cohort. SAVR for patients with asymptomatic severe AS is supported by 2 published randomized trials compared to only 1 randomized trial on TAVR with the Edwards Sapien 3 valve. Importantly, only SAVR demonstrated mortality benefit in asymptomatic severe AS in both surgical trials, whereas the benefit in TAVR was limited to a reduction in unplanned hospitalization for cardiovascular causes without any observed mortality benefit. As a result, the updated 2025 joint European Society of Cardiology (ESC) / European Society of Cardiothoracic Surgery (EACTS) valve guidelines recommended a Class I indication for SAVR in asymptomatic severe AS, but only Class IIa for TAVR. While we agree that TAVR demonstrates short-term readmission benefit in patients with asymptomatic severe AS, longer-term data are warranted to confirm the clinical benefit of TAVR in asymptomatic severe AS before recommending its widespread use. Furthermore, it remains unclear what the long-term impact of earlier intervention will be on later reintervention, particularly when longer term durability data are lacking for TAVR. In my mind, the EARLY TAVR trial consists of highly selected patients, just like in any RCT, and so now that the Sapien 3 valve is FDA approved for this indication, the ACC/STS TVT registry will provide the gold standard platform to track real-world outcomes of asymptomatic severe AS patients undergoing TAVR in the US, many of whom will be Medicare beneficiaries. This is critical to be able to compare whether real-world outcomes of TAVR in a new indication mirror those reported in an RCT, much like what happened to TAVR in low surgical risk patients with symptomatic severe AS.

Point #2: Cumulative evidence demonstrates that TAVR no longer requires CED and is reasonable and necessary for the benefit category of inpatient hospital services and physician services in the treatment of AS.

RESPONSE:
A) The critical role that the ACC/STS TVT registry has played in maintaining quality and outcomes of TAVR with newer technologies and expanding indications among Medicare beneficiaries
TAVR has become a Class I indication in patients with symptomatic severe AS across all surgical risk patients in the current valve guidelines based on the large body of randomized trial and real-world registry evidence after FDA approval. Critically, the STS/ACC TVT registry has served as a benchmark on the evaluation and reporting of TAVR safety and quality outcomes across >860 centers in the United States. The TVT registry continues to generate a large body of evidence on TAVR in the US, including the importance of the volume-outcome relationship and indications beyond the initial FDA approval, such as valve-in-valve procedures and patients with pure aortic regurgitation. The largest body of randomized trial and registry evidence remain only in patients with symptomatic severe AS with trileaflet anatomies. Randomized trials on TAVR vs SAVR in bicuspid anatomies are poised to begin and real-word registry data in this patient population are essential. Furthermore, valve-in-valve procedures, especially redo-TAVR in failed transcatheter aortic valves, are increasing in volume with only limited short- and mid-term data in the United States. Since TAVR with the Edwards Sapien 3 valve has only recently been FDA approved for asymptomatic severe AS, it is even more essential to have real-world data captured via the TVT registry on the safety and quality of TAVR in these newly defined populations in the US. In the future, there will be FDA approved novel TAVR devices for use in pure aortic regurgitation and further real-world evidence utilizing the TVT registry to track patient safety and outcomes will be critical. Furthermore, newer indications for TAVR, e.g. symptomatic moderate AS, will emerge in the future. We therefore believe that the notion that “TAVR no longer requires CED” is ill conceived and ongoing TVT registry reporting and continuous development of real-world evidence is paramount to protect public safety and maintain the quality of TAVR performed in the US. The CED is essential for ongoing monitoring of TAVR use presently and in specific expanded patient cohorts as outlined above. Moreover, a non-industry adjudicated registry is essential to obtain unbiased outcomes data in these populations to avoid the significant conflicts that exist with industry funded registries.

B) The integral role of a multidisciplinary heart team in TAVR to guide optimal decision-making in Medicare beneficiaries
One of the key elements in the CED that has resulted in the excellent quality outcomes for patients receiving TAVR is the integral role of heart team in guiding the optimal therapy for patients with symptomatic severe aortic stenosis. In fact, the reduction in complications and mortality, and the continued observed improvement in quality of life across the entire spectrum of care for patients with AS is a direct result of the heart team. The joint decision making between an interventional cardiologist and cardiac surgeon directly leads to improved selection of the appropriate treatment option for our patients, be it TAVR or SAVR or even medical therapy in futile patients. Furthermore, the heart team leads to better procedural-related outcomes and quality of life across all therapies chosen for patients in need of aortic valve replacement regardless of technique chosen. This is particularly important in recipients of Medicare and Medicaid services including those with complex medical and social histories and complex anatomies where not having a team approach would jeopardize patient safety. Dismantling the heart team in joint decision making and procedures would risk inappropriate use of TAVR in AS patients. We strongly advocate for maintaining the CED to preserve the heart team concept, thereby maintaining patient safety and procedural quality. We have experienced an improvement in outcomes and quality in our TAVR program, as a direct result of close collaboration among heart team members including interventional cardiologists and surgeons, to offer the most holistic and comprehensive recommendation and treatment plan for all our patients with aortic valve disease. This heart team concept, similar to those in transplant and oncology, should be maintained in future NCD in order to maintain the quality of TAVR nationwide.

Point #3: Updates to the TAVR NCD are needed to streamline and remove outdated and burdensome requirements that create barriers to patient care.

RESPONSE: While local site requirements that create barriers to patient care may vary due to geographical and local factors, access to care should NOT be compromised in any way or form by a reduction in quality. I believe that the evolution of TAVR will continue to be a simpler, safer and effective procedure, and access to care will improve as a result of technological and procedural improvements. The role of a multidisciplinary heart team should be maintained to offer patients best care possible, with the best quality possible at the local community. Removing these barriers may or may not improve patient access, as we have witnessed the proliferation of TAVR centers more in urban than rural areas, and may risk compromising outcomes and quality. I urge an ongoing data tracking on TAVR expansion and quality across all the TAVR sites to determine if this access to care and quality relationship can be maintained to provide the utmost top notched care that we strive for among our Medicare beneficiaries.

Less

I have had the opportunity to serve as the national PI on a number of the TAVR trials and have completed about 2,500 cases at my institution. The procedure is relatively straight forward but the decision making can be much more complex. There is a growing indication in the literature of cases outside of the guidelines receiving TAVR. A strong and knowledgeable heart team is the best way to ensure evidence driven application of this technology. I believe the heart team to be integral to maintaining patient safety and acceptable outcomes. Involvement of both cardiology and cardiac surgery is fundamental to maintaining this balanced decision making. I admit my bias as a cardiac surgeon but have experience firsthand how working together leads to better decision making. I believe the push to change the NCD is predicated on the procedure being easy and therefor anyone can do this. This ignores the most important part of almost everything we do - making the proper decisions before acting. I also believe that requiring sites to submit data to the TVT both encourages better care and continues to inform the field and our patients of outcomes. I sincerely hope we stay with what has been and continues to be an outstanding success.

Michael J. Reardon, M.D.
Professor of Cardiothoracic Surgery
Allison family Distinguished Chair of Cardiovascular Research
Houston Methodist Hospital

Less

Transcatheter Aortic Valve Replacement (TAVR) is now a mature, well-established therapy with over a decade of clinical experience and more than one million valves implanted worldwide. The current CMS mandate requiring both an interventional cardiologist (IC) and cardiothoracic surgeon (CS) to participate in pre-procedural decision-making and intra-operative co-management for every TAVR procedure is increasingly burdensome and inconsistent with other transcatheter valve interventions, including mitral and tricuspid procedures. This requirement unintentionally restricts access by tying two highly specialized proceduralists to a single case, thereby reducing capacity for other patients in need of transcatheter or surgical care. Modernizing the TAVR heart team requirement to a single proceduralist model, where the primary operator may be either an interventional cardiologist or a cardiothoracic surgeon, will aid in preserving access for patients.
Maintaining the heart team as a collaborative framework rather than a procedural mandate respects the expertise of both the cardiac surgeons and interventional cardiologists, preserves their procedural autonomy, and allows health systems to deploy skills where they are most critically needed.
Updating CMS policy to allow a single qualified proceduralist, whether cardiothoracic surgeon or interventional cardiologist—while maintaining appropriate surgical backup will improve patient access, reduce delays, and reflect the current state of TAVR practice without compromising safety or outcomes.

Less

On behalf of The Mended Hearts, Inc., the nation’s leading peer-to-peer support organization for heart disease patients, caregivers, and families, we appreciate the opportunity to comment on the National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) for the treatment of aortic stenosis (AS).

The Mended Hearts, Inc. represents tens of thousands of individuals living with cardiovascular disease, many of whom have undergone—or may benefit from—TAVR. From the patient perspective, timely access to safe, effective, and evidence-based therapies is essential. We urge CMS to modernize the TAVR National Coverage Determination (NCD) to reflect the current state of clinical evidence and real-world practice.

Sunsetting Coverage with Evidence Development (CED) Requirements: To be eligible for TAVR Medicare coverage, participating hospitals and centers must meet procedural volume requirements specified in the NCD with CED. With the original NCD with CED, the procedural volume requirements were used as a surrogate for quality of care. After more than a decade of extensive evidence development, it is clear that volume requirements for TAVR are both outdated and arbitrary. The body of evidence supporting TAVR is now extensive, mature, and compelling. Multiple randomized controlled trials and long-term follow-up data demonstrate that TAVR is reasonable and necessary for the treatment of aortic stenosis across patient risk profiles. Continued Coverage with Evidence Development requirements are no longer warranted and may unnecessarily limit access for Medicare beneficiaries. CMS should sunset CED requirements for TAVR and recognize it as a well-established, evidence-based therapy.

Expanding Indications to Reflect Current Clinical Practice: The existing TAVR NCD has not kept pace with the rapid evolution of clinical evidence and FDA-approved indications. As new indications are established through rigorous trials and regulatory review, the NCD must be sufficiently flexible to allow timely patient access without prolonged coverage delays. An updated policy should enable beneficiaries to benefit from clinically appropriate TAVR use as standards of care continue to advance.

Removing Barriers to Patient Access: Outdated and burdensome NCD requirements—such as rigid procedural, facility, or data submission mandates—can delay care and restrict patient choice without improving outcomes. These barriers are particularly challenging for patients in rural or underserved communities. Updating the NCD to remove unnecessary requirements will help ensure that decisions about TAVR candidacy remain centered on shared decision-making between patients and their clinical care teams.

Modernizing the TAVR NCD is a critical step toward ensuring Medicare beneficiaries have equitable, timely access to life-saving cardiovascular care. The Mended Hearts, Inc. urges CMS to update the policy to expand indications, sunset CED requirements, and remove outdated barriers that no longer serve patients’ best interests.

Thank you for considering the patient voice in this important coverage determination. We look forward to continued engagement with CMS to advance patient-centered cardiovascular care.

Sincerely,

The Mended Hearts, Inc.

Less

I appreciate the opportunity to comment on CMS’s reconsideration of the National Coverage Determination for TAVR.

From the perspective of someone working closely with a structural heart program and directly involved in monitoring quality, outcomes, and care processes for TAVR patients, I believe certain requirements within the current NCD can unintentionally slow patient access to TAVR for a disease that often progresses quickly. While the intent of the policy is appropriate and patient safety is paramount, the cumulative effect of required steps can create delays that do not always add meaningful clinical value.

The heart team approach remains critically important and should continue to be a cornerstone of TAVR care. Multidisciplinary input clearly improves decision-making, particularly for complex or borderline cases. That said, requiring multiple sequential consultations for every patient, including a general cardiologist, a structural cardiologist, and a cardiac surgeon, can create unnecessary redundancy in straightforward cases where candidacy is already clear. From a patient perspective, this often results in added visits, repeated conversations, and longer time to treatment without changing the ultimate care plan.

In practice, the current NCD also drives conservative internal workflows within hospitals. Even when delays are not directly mandated by CMS, programs often design processes to strictly adhere to perceived requirements, which can lead to additional administrative and scheduling burdens. These systems prioritize compliance but may inadvertently hinder timely access to care for Medicare beneficiaries with symptomatic aortic stenosis.

Current evidence and real-world experience support TAVR as a reasonable and necessary treatment option for many Medicare patients. An updated coverage policy that preserves the heart team concept while allowing greater flexibility based on patient complexity and clinical judgment would better reflect modern practice and improve access without compromising safety or outcomes.

Thank you for considering this input as part of the NCD reconsideration process.

Less

I do not agree with reducing the operators for TAVR to just a single operator. The beauty of TAVR revolves around a team. The valve team is instrumental in evaluating patients, bringing an instant multidisciplinary approach to patients, and bringing a multidisciplinary treatment to a patient. We have all heard two sets of eyes are better than one. This is ages old. It matters in these patients to have an evaluation, treatment plan, and treatment with outcome studies followed by a multidisciplinary team. A team is always better than any individual.

Less

CMS’s consideration of expanding national coverage for TAVR to asymptomatic patients and revisiting mandatory surgeon involvement is timely and appropriate. With growing evidence of benefit in selected asymptomatic patients—and alignment with current clinical guideline indications—coverage should be extended when the heart team determines that a specific patient is likely to benefit. This does not imply indiscriminate use, but rather supports individualized, evidence-based decision-making.
Regarding procedural staffing, while the heart team model and multidisciplinary evaluation remain important, the contemporary TAVR population increasingly consists of patients who clearly benefit from a transcatheter approach. Heart team discussions are effective at identifying patients better suited for SAVR, but requiring universal, in-person evaluation and procedural involvement from all disciplines often delays care without adding proportional value. In many centers, the second operator’s role is largely passive, serving primarily as backup—paralleling the historical evolution seen with PCI.
A more selective approach to surgeon involvement, rather than a universal mandate, would better reflect current practice patterns, procedural maturity, and efficiency, while preserving patient safety and appropriate surgical input when clinically indicated.

Less

I am a Cardiovascular surgeon at a high volume center performing around 500 TAVR procedures a year. For the last decade and half, TAVR has been a blessing for many patients needing definitive management of aortic stenosis and the indications and expertise have expanded over this time period.

The Heart Team approach which mandates both CT surgeons and Interventional cardiologists to be involved in the decision making and performance of the procedure has made TAVR a very safe and high quality procedure. The combined specialty evaluation and treatment model has been one of the best things that has happened for patient care.

I would recommend that the recommendations should continue to mandate both CT surgeons and Interventional cardiologists to evaluate patients and perform the procedures together.

Making this procedure a single operator one has major drawbacks and will adversely affect our patients. It may lead to bias in patient selection, unsafe situations where sometimes backup can be delayed, lack of ownership of patient care in times of emergency situations, obstacle for growth as a team that can tailor the best treatment option for any particular patient, to name a few.

I have been a cardiovascular surgeon in a small volume cardiac center without a designated heart team, in the past and I can certainly speak to the disadvantages of those setups with my own experience.

If you want your family member to have this procedure, you definitely need a surgeon to be involved right from the beginning of evaluation to the performance and completion of procedure and to have a surgical backup readily available during the procedure in case of mishaps or complications. Even though the incidence of major complications are low, if it happens, it still is detrimental to human life and we as healthcare providers should not let that happen to our patients at any cost.

Less

TAVR has transformed care for severe aortic stenosis across surgical risk profiles, offering excellent procedural safety and outcomes compared with traditional surgical aortic valve replacement (SAVR). As TAVR indications expand to asymptomatic severe aortic stenosis, recent evidence highlights clear benefits:

• In the EARLY TAVR Trial, early TAVR in asymptomatic severe aortic stenosis patients significantly reduced the composite endpoint of death, stroke, or unplanned cardiovascular hospitalization (26.8% vs. 45.3%) compared with clinical surveillance over a median of 3.8 years.
• Numeric reductions in stroke (4.2% vs. 6.7%) and lower rates of rapid symptom progression and emergent hospitalizations were also reported in early intervention arms.
• A striking 87% of asymptomatic patients in the surveillance arm progressed to valve replacement within follow-up, indicating early intervention may prevent deterioration.

These data support revisiting TAVR coverage and timing guidelines to encompass early intervention strategies that improve long-term outcomes while decreasing unplanned care.

While historically TAVR was developed via heart team models involving CT surgeons, the role has evolved:

• Workforce projections from HRSA and specialty societies indicate a significant CT surgeon shortage ahead, with increased demand alongside retirements and population aging. One projection suggests a potential 30% shortfall by 2035 if workforce expansion does not keep pace.
• Current procedural standards, including those referenced in CMS and professional society policies, require a cardiac surgeon and an interventional cardiologist on heart teams for TAVR evaluation and performance. Recent changes reduced the historical requirement for two CT surgeon evaluations to one surgeon plus one interventionalist, indicating acknowledgement of evolving practice and resource constraints.

Despite robust training pipelines, demand for CT surgical expertise is projected to grow due to aging populations, complex cardiac care needs, and increased case volume across cardiac indications. Balancing the need for surgical oversight with the efficient use of CT surgeons’ time is therefore essential for access and quality.

In many contemporary TAVR cases, especially standard transfemoral procedures in anatomically suitable patients, the active intra-procedure role for a CT surgeon is limited. Clinical data and expert commentaries report:

• The incidence of complications requiring emergent conversion to open surgery during TAVR has progressively declined, often cited as well under 1% in experienced centers.
• Modern heart teams utilize advanced imaging (e.g., CT angiography, echo) and refined procedural techniques that mitigate many risks that previously necessitated routine surgical readiness.

While a CT surgeon’s involvement remains critically important for pre-procedure assessment, multidisciplinary decision making, and management of complex cases, requiring dual surgeon involvement for every TAVR can lead to inefficient use of scarce surgical resources, potentially delaying care access and deferring CT surgeons from higher-acuity surgical needs such as complex open procedures, emergency cardiovascular care, and structural surgical backlog.

To enhance access while preserving quality:

1. Support heart team flexibility: Recommend that procedural participation requirements allow appropriately trained interventional cardiologists to perform standard transfemoral TAVR with surgeon availability for complex cases or emergent needs rather than mandatory positional presence in every case.
2. Align coverage with evidence: Expand coverage flexibility for asymptomatic severe aortic stenosis TAVR indications in line with outcomes data demonstrating reduced adverse events and improved quality-adjusted life years.
3. Promote workforce sustainability: Recognize the projected CT surgeon shortage in coverage policy language and facilitate policies that ensure efficient use of surgical expertise, support training pathways, and optimize multidisciplinary care models that deploy CT surgeons where they add the greatest value.

In summary, TAVR’s success and expanding indications offer extraordinary patient benefits, but current coverage requirements should evolve to reflect clinical data and workforce realities. Evaluating the utilization of CT surgeon resources within this context will help CMS maintain patient safety while improving access, efficiency, and long-term outcomes across the Medicare population.

Less

I strongly oppose the proposed changes. A multidisciplinary approach to complex cardiovascular disease has been one of the most significant breakthroughs in our time. And, it has been born out of TAVR. It has built an import bridge between specialties. This has done nothing but yield benefits for our patients. Further, thanks to the 2 implanter requirement, outcomes most certainly are unquestionably better with countless avoided complications. 2 different points of view with the same goal has revolutionized patient outcomes.

Less

With over 30 years of cardiac related healthcare management experience, I would like to make a strong comment to advocate for the continuance of the heart team approach. The heart team approach allows for the best chance for patients to be educated on all the alternatives to treat their heart valve and other cardiac related conditions. These are complex health conditions with life and death consequences, and the heart team approach allows for the best chance for a true shared decision-making experience for each patient's individual circumstances.

Less

Transcatheter aortic valve replacement has revolutionized the practice of medicine for the treatment of aortic stenosis. The success of TAVR has been predicated on the heart team approach which allows for both the surgical and cardiology assessment of patients in order to choose appropriate candidates. It is also the intraprocedural collaboration which has aided in the technical success and quality outcomes. Patient safety is drastically improved by the presence of cardiothoracic surgeons during TAVR procedures to provide life-saving measures during potential TAVR complications. Program requirements that ensure hospitals and physicians meet standards consistent with clinical consensus and guideline-based care are necessary. It is also critical that we continue to participate in registries to sustain rigorous outcomes measurement and evidence-based development.

Less

As a cardiac surgeon, and the co-director of the structural heart program and surgical director of structural heart for a busy program, I am writing to strongly disagree with the proposed changes to the NCD for TAVR. The heart team (IC and CT surgeons) surrounding the TAVR program has been one of the best developments in cardiovascular disease. Having independent evaluations by a cardiologist and a surgeon are imperative, and having both present participating in the implants is also crucial. I will add that CT surgeons are truly the only physicians who can provide an accurate opinion with regard to candidacy for both TAVR and SAVR as they perform both of these procedures. It is also crucial that we continue to maintain the robust TVT registry to allow us to continue to improve this procedure and the care of our patients.

Less

I am writing to express my strong support for maintaining and expanding access to Transcatheter Aortic Valve Replacement (TAVR) as a standard-of-care treatment for patients with severe aortic stenosis (AS), including both symptomatic and asymptomatic individuals.

Decades of rigorous clinical data have now firmly established TAVR as a safe, effective, and lifesaving intervention across all surgical risk categories. Landmark randomized controlled trials—PARTNER 3, Evolut Low Risk, and others—have shown TAVR to be noninferior or superior to surgical aortic valve replacement (SAVR) in terms of mortality, stroke, rehospitalization, and functional recovery, particularly in elderly and frail populations.

Importantly, emerging evidence—such as the EARLY TAVR trial—supports the benefit of TAVR in asymptomatic severe AS patients who demonstrate early markers of left ventricular dysfunction, abnormal stress testing, or elevated cardiac biomarkers. Waiting for symptoms to develop in these patients can result in irreversible cardiac damage and missed opportunities for optimal outcomes.

Despite these advances, undertreatment of severe AS remains a significant and concerning issue, with up to 40% of eligible patients still not receiving definitive therapy. Access barriers, particularly in non-academic and underserved regions, continue to prevent timely treatment for many. One critical and addressable barrier is the current CMS requirement mandating the presence of two operators—a cardiac surgeon and an interventional cardiologist—for every TAVR procedure.

While this dual-operator model was appropriate during the initial phase of TAVR adoption, the field has matured substantially. TAVR programs now operate within multidisciplinary heart teams under strict quality metrics and institutional oversight. The two-operator mandate has outlived its utility and has become a logistical bottleneck, limiting procedural flexibility, delaying care, and restricting access—especially in lower-volume centers or areas with limited specialist availability.

I urge CMS to revise the NCD to allow a single qualified operator—whether a cardiac surgeon or an interventional cardiologist—to perform TAVR, with the other available for backup as clinically indicated. This change would preserve safety and heart team collaboration while allowing sites to optimize procedural staffing based on expertise and patient complexity.

In summary, TAVR is an established, guideline-supported therapy for both symptomatic and asymptomatic patients with severe AS. Revising operator requirements is a necessary step to modernize CMS policy, reduce undertreatment, and ensure equitable access to this lifesaving therapy across diverse care settings.

Less

Background for request/comments
Since its initial approval, TAVR has undergone significant evolution in device technology, procedural technique, operator experience, and patient selection. These advancements have resulted in improved procedural safety, reduced complication rates, shorter hospital length of stay, and excellent short- and long-term outcomes across a broad range of patient risk profiles.
Current ACC/AHA valve disease guidelines now support intervention in select asymptomatic patients with severe aortic stenosis who demonstrate high-risk clinical, hemodynamic, or myocardial features. However, existing CMS NCD and NCDR participation requirements have not fully evolved to reflect this evidence or current guideline recommendations.
In addition, the existing mandate for two operators to be present during every TAVR procedure, regardless of patient risk or procedural complexity, no longer reflects modern practice patterns or the maturity of TAVR programs nationwide.

Request 1: Expand Access to TAVR for Asymptomatic Severe Aortic Stenosis

We respectfully request that CMS update NCDR-related TAVR coverage and participation requirements to allow access for asymptomatic patients who meet established criteria for severe aortic stenosis, consistent with contemporary guideline-directed and evidence-based care.
Emerging and established data demonstrate that select asymptomatic patients—particularly those with:

Left ventricular systolic dysfunction

Very high transvalvular gradients

Rapid disease progression

Abnormal exercise testing

Biomarkers or imaging evidence of myocardial injury or remodeling
may benefit from earlier valve intervention, including TAVR. Earlier treatment in these patients may prevent irreversible myocardial damage, reduce heart failure hospitalizations, and improve long-term survival and quality of life.
We propose that CMS permit coverage for TAVR in asymptomatic patients when eligibility is:

Determined by a multidisciplinary heart team

Supported by clearly defined clinical and imaging criteria

Documented through continued mandatory participation in the NCDR

This approach maintains strong quality oversight while improving equitable access to evidence-based care.

Request 2: Flexibility in the Requirement for Two Operators During TAVR
We further request that CMS revise the current requirement mandating the presence of two operators for all TAVR procedures, irrespective of patient complexity or procedural risk.
While this requirement was appropriate during the early adoption phase of TAVR, contemporary experience demonstrates that procedural risk varies significantly based on:

Patient comorbidities and frailty

Anatomic complexity

Access route

Procedural risk classification
We recommend that CMS allow operator staffing flexibility, with the decision guided by patient risk stratification, procedural complexity, and institutional expertise. Under this framework:

Low-risk, routine transfemoral TAVR cases may be safely performed by a single experienced primary operator supported by a comprehensive structural heart team

Higher-risk or complex cases would continue to warrant dual-operator participation
This model preserves patient safety, supports workforce sustainability, improves operational efficiency, and enhances access to care—particularly in high-volume or resource-constrained programs—without compromising quality outcomes.

Quality, Safety, and Program Oversight
These requested updates would not diminish CMS quality or safety expectations. All participating programs would remain accountable through:

Mandatory NCDR participation

Transparent reporting of outcomes

Benchmarking against national performance standards

Continued heart team-based decision-making
CMS would retain full oversight authority and the ability to intervene if quality metrics or outcomes fall below established thresholds.

Conclusion
Updating NCDR-related TAVR requirements to reflect contemporary evidence and guideline-directed care will enhance patient-centered access, optimize resource utilization, and support continued innovation in structural heart disease management.
We respectfully request CMS consideration of these recommendations and welcome the opportunity to participate in further stakeholder engagement or policy discussion. Best,
Thank you for your time and consideration to our requests from Baptist Health Heart and Vascular Institute.

Less

WomenHeart: The National Coalition for Women with Heart Disease urges CMS to update the TAVR NCD to expand timely access for patients with aortic stenosis. This is particularly important for women who are often older at diagnosis, present with more severe symptoms, and have anatomical differences that may make surgery more complex. Evidence shows TAVR outcomes in women are equal to or better than in men, yet women are historically under-referred for valve replacement.

We support expanding TAVR indications for symptomatic and select asymptomatic patients and sunsetting CED requirements, which are no longer needed given strong evidence of safety and effectiveness. Implemented with the intent to protect patient outcomes, current policies can lead to inequitable dispersion of TAVR in socioeconomically disadvantaged areas. Restricting TAVR centers based on volume can create longer travel distances, delays, and lower utilization rates, disproportionately affecting women. Expanding TAVR availability based on patient and community need will improve outcomes, reduce mortality, and ensure women nationwide can receive life-saving care.

Respectfully submitted,
WomenHeart: The National Coalition for Women with Heart Disease

Less

We support updating the National Coverage Analysis (NCA) for transcatheter aortic valve replacement (TAVR) to reflect contemporary evidence and clinical practice, including coverage for selected patients with asymptomatic severe aortic stenosis who have high-risk features or objective markers of adverse prognosis. Randomized and observational data demonstrate that earlier intervention in severe aortic stenosis can reduce heart failure events, prevent irreversible myocardial damage, and improve long-term outcomes compared with watchful waiting in appropriately selected patients [Kang et al., and Généreux et al]. In parallel, conversion from TAVR to open surgery has become exceedingly rare (<1%), particularly in experienced, high-volume centers with mature multidisciplinary programs and standardized protocols [Mack et al., and Carroll et al.]. Furthermore, contemporary TAVR is routinely performed using minimalist, percutaneous techniques by a single experienced operator, and available evidence does not support a requirement for the physical presence of a cardiac surgeon in the procedure room when appropriate institutional safeguards, rapid transfer protocols, and outcome benchmarks are in place [Carroll et al., and Vlastra et al]. Therefore, requirements for routine on-site mandatory surgical presence during TAVR should be reconsidered for high-volume centers with demonstrated outcomes, as such mandates no longer reflect current procedural safety, introduce unnecessary logistical and staffing burdens, and may limit beneficiary access without improving patient safety. A risk-based, outcomes-driven framework aligned with contemporary evidence, quality metrics, and center experience would better serve Medicare beneficiaries while maintaining program accountability.

Less

December 16, 2025:

Centers for Medicare & Medicaid Services
Coverage and Analysis Group
7500 Security Boulevard
Baltimore, MD 21244

RE: Public Comment on Proposed National Coverage Determination for Transcatheter

Aortic Valve Replacement, CAG-00430R2
Submitted Electronically: https://www.cms.gov/medicare-coverage-database/view/national-submit-public-comment.aspx

Dear Members of the Coverage and Analysis Group:

On behalf of Baptist Health Systems in Kentucky and Indiana, we are writing to express our strong support for Edwards Lifesciences' formal request to update the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). Baptist Health operates a comprehensive cardiovascular service line spanning eight hospitals in Kentucky and one in Indiana, providing structural heart interventions to our diverse patient population. Our Cardiovascular Service Line oversees the Division of Structural Heart and have witnessed firsthand the transformative evolution of this technology and its profound impact on patient outcomes in Kentucky and Indiana.

We enthusiastically support all four components of the NCD request: (1) expanded coverage for asymptomatic patients with severe aortic stenosis, (2) elimination of Coverage with Evidence Development (CED) requirements, (3) removal of outdated access barriers, and (4) transition from volume-based to quality-based performance metrics. Each of these modifications is scientifically justified, clinically necessary, and aligned with the best interests of Medicare beneficiaries.

I. Support for Expanded Coverage: Early TAVR in Asymptomatic Severe Aortic Stenosis

The most compelling evidence supporting early intervention comes from the landmark EARLY TAVR trial, published in the New England Journal of Medicine in October 2024.¹ This multi-center randomized controlled trial enrolled 901 patients with rigorously confirmed asymptomatic severe aortic stenosis across 75 sites in the United States and Canada. The trial employed protocol-mandated stress testing to ensure true asymptomatic status, establishing the highest methodological standard for patient selection in aortic stenosis research to date.

The results demonstrated unequivocal superiority of early TAVR over guideline- recommended clinical surveillance. At a median follow-up of 3.8 years, the primary composite endpoint of death, stroke, or unplanned cardiovascular hospitalization occurred in 26.8% of patients randomized to early TAVR compared with 45.3% in the clinical surveillance group (hazard ratio 0.50; 95% CI 0.40-0.63; P<0.001).¹ This represents an absolute risk reduction of 18.5 percentage points—a magnitude of benefit rarely observed in cardiovascular interventional trials.

Critically, examination of the individual components reveals that early TAVR was beneficial across all major outcomes. Death occurred in 8.4% of early TAVR patients versus 9.2% of surveillance patients. Stroke occurred in 4.2% versus 6.7%, respectively. Most strikingly, unplanned hospitalization for cardiovascular causes occurred in 20.9% of early TAVR patients compared with 41.7% of surveillance patients—a 50% reduction in this clinically meaningful and economically significant endpoint.¹

Quality of life outcomes strongly favored early intervention. At two years, 86.6% of early TAVR patients achieved a favorable health status outcome (defined as alive with KCCQ score =75 and no decrease >10 points from baseline) compared with only 68.0% in the surveillance group (P<0.001).² Furthermore, early TAVR was associated with superior preservation of left ventricular and left atrial health at two years, suggesting prevention of irreversible cardiac remodeling.

Perhaps most illuminating was the natural history observed in the surveillance arm. Within six months of randomization, 26.2% of patients initially classified as asymptomatic required conversion to aortic valve replacement, many presenting with progressive or advanced symptoms. By 12 months, this proportion increased to 47.2%, and ultimately 87% of surveillance patients underwent valve replacement during follow-up.³ This demonstrates that the current paradigm of 'watchful waiting' subjects the majority of patients to symptomatic deterioration, emergency hospitalizations, and intervention under less favorable circumstances. As Dr. Philippe Généreux, the trial's principal investigator, aptly stated: 'Without intervention, patients rigorously confirmed as asymptomatic experienced unpredictable and rapid decline with numerous adverse outcomes.'³

II. Support for Elimination of Coverage with Evidence Development

Requirements

The Coverage with Evidence Development framework has served an important historical purpose in the early adoption of TAVR technology. Between 2012 and 2019, the CED program successfully facilitated the accumulation of high-quality registry data that has informed clinical practice and regulatory decisions. However, TAVR has now matured into a well-established, evidence-based therapy with over a decade of real-world safety and e?cacy data.

The STS/ACC TVT Registry has captured outcomes on over 500,000 commercial TAVR procedures across more than 800 sites through 2024. Recent registry analyses demonstrate 30-day mortality rates of 0.8% in low-risk patients and stroke rates of 1.7%— outcomes that rival or exceed those of surgical aortic valve replacement while o?ering substantially faster recovery and reduced morbidity.⁴

The continuation of CED requirements imposes administrative burdens on hospitals and clinical teams without commensurate benefit to evidence generation or patient care. Modern quality registries, including the ongoing TVT Registry, already capture the essential safety and e?ectiveness data needed for quality improvement and regulatory oversight. Importantly, CED requirements create potential barriers to access, particularly for smaller community hospitals that may face challenges meeting registry submission requirements despite having qualified teams and appropriate infrastructure.

We note that other advanced cardiovascular interventions, including percutaneous coronary intervention and left atrial appendage closure, have transitioned away from mandatory CED frameworks as evidence matured. TAVR has achieved an equivalent level of evidence maturity and should be a?orded the same regulatory evolution. Elimination of CED would streamline coverage while maintaining robust quality oversight through voluntary registry participation and emerging quality metrics.

III. Support for Removal of Outdated Access Barriers

Current NCD requirements include procedural and infrastructure mandates that were appropriate during TAVR's investigational phase but now represent unnecessary barriers to patient access. These include requirements for on-site cardiac surgery programs, specific pre-procedural imaging protocols, and mandatory multidisciplinary team structures that, while philosophically sound, are not consistently supported by outcomes data. Contemporary TAVR can be performed safely with appropriate patient selection, modern valve technology, and comprehensive pre-procedural planning. The requirement for on-site cardiac surgery, while providing theoretical backup capability, has become increasingly disconnected from actual practice patterns. Modern TAVR programs report surgical conversion rates of <1%, and when conversion is required, it rarely occurs emergently.⁵ Well-established transfer protocols can adequately address the rare circumstance requiring surgical intervention.

Similarly, overly prescriptive requirements regarding imaging modalities and timing create unnecessary rigidity. While comprehensive imaging is essential for procedural planning, the specific modalities and protocols should be left to the discretion of the Heart Team based on individual patient anatomy and local expertise. Modern computed tomography angiography protocols provide excellent anatomic detail and are now the standard for procedural planning across most centers.

Removing these prescriptive barriers would enable qualified programs to provide TAVR services in settings that may not meet current structural criteria but possess the necessary clinical expertise, quality infrastructure, and patient safety systems. This is particularly relevant for rural and underserved populations who face geographic barriers to care at large academic centers. Outcome-based requirements, rather than process-based requirements, should guide program qualification.

IV. Support for Transition from Volume to Quality-Based Performance Metrics

The proposed transition from volume-based to quality-based metrics represents a critical evolution in TAVR oversight. While procedural volume requirements served an important gatekeeping function during TAVR's early adoption, the contemporary evidence regarding the volume-outcome relationship has become increasingly nuanced and suggests that volume may serve as an imperfect proxy for quality.

Evidence Regarding Volume-Outcome Relationships

The most frequently cited evidence supporting volume requirements comes from the 2019 TVT Registry analysis by Vemulapalli et al., which examined 113,662 TAVR procedures from 2015-2017.⁶ This analysis demonstrated an inverse relationship between hospital volume and 30-day mortality, with the lowest-volume quartile (mean 27 procedures annually) showing 3.19% mortality versus 2.66% in the highest-volume quartile (mean 143 procedures annually; odds ratio 1.21, P=0.02). While statistically significant, this represented an absolute di?erence of only 0.53 percentage points.

Several subsequent analyses have challenged the generalizability and clinical significance of these findings. A 2024 analysis of the same TVT Registry examining data from 2017-2023 found that while lower-volume sites had modestly higher odds of major in- hospital complications (OR 1.19; 95% CI 1.08-1.32), there was no significant di?erence in failure-to-rescue rates (OR 1.06; 95% CI 0.92-1.21).⁷ This suggests that low-volume centers may select higher-risk patients but manage complications with equivalent e?ectiveness. Moreover, a 2019 analysis examining the joint e?ect of surgical aortic valve replacement (SAVR) and TAVR volumes found that SAVR volume alone was not independently associated with better TAVR outcomes after adjustment.⁸ When hospitals with high TAVR volume were stratified by SAVR volume, outcomes were primarily driven by TAVR experience rather than overall surgical valve volume. This challenges the premise that minimum surgical volumes are necessary for TAVR program quality.

Importantly, volume-outcome relationships vary across di?erent structural heart procedures. A 2024 analysis comparing TAVR and mitral transcatheter edge-to-edge repair (TEER) found only modest correlation between hospital-level volumes (r=0.48) and low correlation of outcomes between procedures.⁹ This demonstrates that institutional expertise in one structural heart procedure does not automatically translate to excellence in another, further undermining volume as a universal quality marker.

Proposed Quality-Based Metrics

We strongly support the implementation of clinically meaningful quality metrics derived from the STS/ACC TVT Registry. The following metrics represent evidence-based, patient- centered outcomes that more accurately reflect program quality than procedural volume:

1. Thirty-Day All-Cause Mortality: Risk-adjusted mortality remains the gold standard outcome metric. Contemporary low-risk TAVR programs should achieve mortality rates below 1.5%.
2. Cerebrovascular Events (Stroke/TIA): Thirty-day stroke rates should be monitored and publicly reported, with risk-adjusted rates below 2.5% representing acceptable performance.
3. Acute Kidney Injury: AKI Stage II or greater, or new dialysis requirement, represents a significant complication that a?ects both short- and long-term outcomes.
4. Major Vascular Complications: As defined by Valve Academic Research Consortium (VARC) criteria, major vascular complications should occur in <5% of trans-femoral cases.
5. Life-Threatening or Major Bleeding: VARC-defined bleeding requiring transfusion =4 units or causing hemodynamic compromise should be tracked and risk-adjusted.
6. Moderate or Severe Paravalvular Leak: Post-procedural paravalvular regurgitation greater than mild has significant prognostic implications and represents a quality metric for procedural technique.
7. Health Status Outcomes Using KCCQ: The Kansas City Cardiomyopathy Questionnaire provides validated, patient-centered assessment of quality of life changes following TAVR. Programs should track and report changes in KCCQ scores at 30 days and one year.¹⁰
8. Shared Decision-Making: Documentation of structured shared decision-making conversations using validated decision aids ensures patient-centered care and appropriate expectations. This metric aligns with best practices across cardiovascular interventions.¹¹

These quality metrics provide meaningful, risk-adjusted assessment of program performance while avoiding the geographic and access disparities inherent in volume requirements. They align with the Centers for Medicare & Medicaid Services' broader Quality Payment Program initiatives and support value-based care delivery.

Baptist Health Systems strongly supports the request for an updated National Coverage Determination for TAVR. The evidence supporting early intervention in asymptomatic severe aortic stenosis is compelling and methodologically rigorous. The elimination of Coverage with Evidence Development requirements recognizes the maturation of TAVR as a standard therapeutic option. The removal of prescriptive access barriers will expand patient access while maintaining appropriate safeguards. Most importantly, the transition to quality-based metrics represents a sophisticated evolution in program oversight that prioritizes outcomes over process measures.

These proposed changes will benefit Medicare beneficiaries through improved access to timely, high-quality care for aortic stenosis while maintaining the robust oversight necessary to ensure patient safety and optimal outcomes. We urge CMS to expeditiously approve these requested modifications to the TAVR National Coverage Determination. Thank you for your consideration of these comments. Should you require additional information or clarification, please do not hesitate to contact me.

Respectfully submitted,
Steven J. Heatherly, M.D., Ph.D., FACC
Vice Chair of Cardiovascular Services
System Medical Director for Heart Failure
Baptist Health System

References
1. Généreux P, Schwartz A, Oldemeyer JB, et al. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med. 2025;392(3):217-227. doi:10.1056/NEJMoa2405880
2. Cardiovascular Research Foundation. Study finds early TAVR can be beneficial for patients with asymptomatic severe aortic stenosis [press release]. October 28, 2024. Accessed December 16, 2025. https://www.crf.org/crf/news-and-events/news/news/3948-study-finds-early-tavr-can-be-beneficial-for-patients-with-asymptomatic-severe-aortic-stenosis
3. Edwards Lifesciences Corporation. Groundbreaking data demonstrate superiority of EARLY TAVR in asymptomatic severe aortic stenosis patients [press release]. October 28, 2024. Accessed December 16, 2025. https://www.edwards.com/newsroom/news/2024-10-28-groundbreaking-data-demonstrate-superiority-of-ear
4. INVAMED. Transcatheter aortic valve replacement (TAVR): patient selection criteria and outcomes in low-risk populations. May 21, 2025. Accessed December 16, 2025. https://invamed.com/transcatheter-aortic-valve-replacement-tavr-patient-selection-criteria-and-outcomes-in-low-risk-populations/
5. Cleveland Clinic. How and why volumes matter in aortic valve replacement. ConsultQD. September 9, 2025. Accessed December 16, 2025. https://consultqd.clevelandclinic.org/how-and-why-volumes-matter-in-aortic-valve-replacement
6. Vemulapalli S, Carroll JD, Mack MJ, et al. Procedural volume and outcomes for transcatheter aortic-valve replacement. N Engl J Med. 2019;380(26):2541-2550. doi:10.1056/ NEJMsa1901109
7. American College of Cardiology. TCT abstracts use NCDR data to evaluate site volume and failure to rescue, impact of CAD and revascularization, more. October 29, 2024. Accessed December 16, 2025. https://www.acc.org/latest-in-cardiology/articles/2024/10/29/20/39/tct-abstracts-use-ncdr-data-to-evaluate-tct-2024
8. Khera R, Pandey A, Kosinski AS, et al. Association between hospital surgical aortic valve replacement volume and transcatheter aortic valve replacement outcomes: findings from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. JAMA Cardiol. 2019;4(7):691-699. doi:10.1001/jamacardio.2019.1673
9. Bach DS, Grubb K, Zhang Y, et al. National variation in hospital MTEER outcomes and correlation with TAVR outcomes: STS/ACC TVT Registry analysis. JACC Cardiovasc Interv. 2024;17(2):190-202. doi:10.1016/j.jcin.2023.11.014
10. Arnold SV, Reynolds MR, Lei Y, et al. Predicting quality of life at 1 year after transcatheter aortic valve replacement in a real-world population. Circ Cardiovasc Qual Outcomes. 2018;11(10):e004693. doi:10.1161/CIRCOUTCOMES.118.004693
11. Coylewright M, Forrest JK, McCabe JM, Nazif TM. TAVR in low-risk patients: FDA approval, the new NCD, and shared decision-making. J Am Coll Cardiol. 2020;75(10):1208-1211. doi:10.1016/j.jacc.2019.12.057

Less

The Global Coalition on Aging (GCOA) appreciates the opportunity to submit a public comment regarding the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). We urge the Centers for Medicare & Medicaid Services (CMS) to modernize NCD 20.32 to reflect current clinical evidence, advances in care delivery, and the realities of an aging Medicare population.

GCOA is an aging and longevity policy organization and cross-sector coalition focused on enabling longer, healthier, and more productive lives. As America ages, Medicare must increasingly prioritize prevention, timely intervention, and avoidance of irreversible decline to improve outcomes while supporting long-term program sustainability.

Aortic stenosis (AS) affects more than two million Americans over age 65 and carries high mortality when left untreated.[1, 2] Yet coverage policy continues to prioritize intervention only after symptom onset. Evidence now shows this approach may result in irreversible cardiac damage, increased hospitalizations, and worse long-term outcomes, reflecting a reactive model increasingly misaligned with modern care.

Over the past decade, TAVR has transformed AS treatment, supported by extensive randomized trial and real-world registry evidence.[3, 4] TAVR improves survival, reduces stroke and heart-failure hospitalizations, shortens recovery, and improves quality of life for older adults, while reducing downstream care burden for Medicare.[5, 6]

Recent evidence further demonstrates that earlier intervention in patients with asymptomatic severe AS leads to superior outcomes compared to clinical surveillance or “watchful waiting.” Randomized trials, observational studies, and meta-analyses consistently show reductions in mortality, heart failure events, and disease progression with earlier valve replacement.[7-19] The EARLY TAVR trial, published in the New England Journal of Medicine, provides particularly compelling evidence that deferring intervention until symptoms emerge may cause avoidable harm.7 CMS policy has not yet aligned with this evidence, despite FDA approval for use in asymptomatic severe AS.

The continued requirement for Coverage with Evidence Development (CED) under the TAVR NCD is also no longer justified. Over more than a decade, CMS’s original CED questions have been comprehensively answered through trials and registries demonstrating excellent procedural safety, durable valve performance beyond ten years, and consistent outcomes across patient populations and quality measurement has matured well beyond early proxy metrics. 20, 21 CMS guidance makes clear that CED should be time-limited; for TAVR, that standard has been met.[22, 23]

Finally, outdated structural and administrative requirements embedded in the current NCD continue to delay care and limit access, particularly in rural and underserved communities. These barriers contribute to persistent undertreatment of AS, with fewer than half of eligible patients receiving aortic valve replacement.[24]

Modernizing the TAVR NCD would improve outcomes for patients while supporting Medicare’s long-term sustainability. Earlier intervention prevents avoidable decline, reduces emergency hospitalizations, and helps older adults maintain independence, advancing both patient well-being and responsible stewardship of Medicare resources. GCOA urges CMS to update NCD 20.32 to reflect today’s evidence and policy priorities.

Michael W. Hodin
CEO
Global Coalition on Aging

Citations
[1] Centers for Disease Control and Prevention, About Heart Valve Disease. 2024: https://www.cdc.gov/heart-disease/about/heart-valve-disease.html.
[2] Clark, M.A., et al., Five-year clinical and economic outcomes among patients with medically managed severe aortic stenosis: results from a Medicare claims analysis. Circ Cardiovasc Qual Outcomes, 2012. 5(5): p. 697-704.
[3] Lauck, S.B., et al., Temporal Changes in Mortality After Transcatheter and Surgical Aortic Valve Replacement: Retrospective Analysis of US Medicare Patients (2012-2019). J Am Heart Assoc, 2021. 10(20): p. e021748.
[4] Carroll, J.D., et al., STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. The Annals of Thoracic Surgery, 2021. 111(2): p. 701-722.
[5] Baron, S.J., et al., Contemporary Costs Associated With Transcatheter Versus Surgical Aortic Valve Replacement in Medicare Beneficiaries. Circ Cardiovasc Interv, 2022. 15(3): p. e011295.
[6] Galper, B.Z., et al., Economic Outcomes of Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis and Low Surgical Risk: Results from the PARTNER 3 Trial. Circulation, 2023. 147(21): p. 1594-1605.
[7] Kim, H.J., et al., Impact of Valve Replacement on Long-Term Survival in Asymptomatic Patients With Severe Aortic Stenosis. Am J Cardiol, 2019. 123(8): p. 1321-1328.
[8] Kang, D.H., et al., Early surgery versus conventional treatment in asymptomatic very severe aortic stenosis. Circulation, 2010. 121(13): p. 1502-1509.
[9] Bohbot, Y., et al., Asymptomatic Severe Aortic Stenosis With Preserved Ejection Fraction: Early Surgery Versus Conservative Management. J Am Coll Cardiol, 2018. 72(23 Pt A): p. 2938-2939.
[10] Le Tourneau, T., et al., Clinical outcome of asymptomatic severe aortic stenosis with medical and surgical management: importance of STS score at diagnosis. Ann Thorac Surg, 2010. 90(6): p. 1876-1883.
[11] Campo, J., et al., Prognosis of Severe Asymptomatic Aortic Stenosis With and Without Surgery. Ann Thorac Surg, 2019. 108(1): p. 74-79.
[12] Celik, M., et al., Asymptomatic Patients with Severe Aortic Stenosis and the Impact of Intervention. J Cardiovasc Dev Dis, 2021. 8(4).
[13] Taniguchi, T., et al., Initial Surgical Versus Conservative Strategies in Patients With Asymptomatic Severe Aortic Stenosis. J Am Coll Cardiol, 2015. 66(25): p. 2827-2838.
[14] Masri, A., et al., Predictors of Long-Term Outcomes in Asymptomatic Patients With Severe Aortic Stenosis and Preserved Left Ventricular Systolic Function Undergoing Exercise Echocardiography. Circ Cardiovasc Imaging, 2016. 9(7).
[15] Pellikka, P.A., et al., Outcome of 622 adults with asymptomatic, hemodynamically significant aortic stenosis during prolonged follow-up. Circulation, 2005. 111(24): p. 3290-3295.
[16] Kang, D.H., et al., Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis. N Engl J Med, 2020. 382(2): p. 111-119.
[17] Banovic, M., et al., Aortic valve replacement versus conservative treatment in asymptomatic severe aortic stenosis: long-term follow-up of the AVATAR trial. Eur Heart J, 2024.
[18] Généreux, P., et al., Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med, 2024. 39
[19] Généreux, P., et al., Aortic Valve Replacement Versus Clinical Surveillance in Asymptomatic Severe Aortic Stenosis: A Systematic Review and Meta-Analysis. Journal of the American College of Cardiology, 2024. Nov 18:S0735-1097(24)10419-6.
[20] Carroll, J.D., et al., STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. Ann Thorac Surg, 2021.111(2): p. 701-722.
[21] Baron, S.J., et al., Long-term risk of reintervention after transcatheter aortic valve replacement. Am Heart J, 2024. 267: p. 44-51.
[22] Centers for Medicare & Medicaid Services, Coverage with Evidence Development, in Ending CED. 2024: https://www.cms.gov/medicare-coverage-database/view/medicare-coverage-document.aspx?mcdid=38.
[23] Congress, U.S., United States Code: Social Security Act, in XVIII.
[24] Brennan, J.M., et al., Racial Differences in the Use of Aortic Valve Replacement for Treatment of Symptomatic Severe Aortic Valve Stenosis in the Transcatheter Aortic Valve Replacement Era. Journal of the American Heart Association, 2020. 9(16): p. e015879.

Less

Dear CMS Coverage and Analysis Group,

My name is Dr. Abhishek Sawant, and I am a cardiologist at Lifetime Heart in Chandler, Arizona. I care daily for Medicare patients with aortic stenosis, many of whom are older, medically complex, and vulnerable to rapid clinical decline. I appreciate CMS opening this National Coverage Analysis to reconsider coverage for transcatheter aortic valve replacement (TAVR).

I am writing in strong support of modernizing NCD 20.32 so that Medicare policy better reflects today’s clinical reality and prioritizes timely, equitable access to life-saving care.

Waiting for symptoms often means waiting too long
In practice, it is rarely clear when a patient with severe aortic stenosis is truly “asymptomatic.” Many patients minimize symptoms, limit activity without realizing it, or deteriorate suddenly. By the time symptoms are undeniable, patients may already be hospitalized or facing worse outcomes. New evidence shows that treating selected patients earlier—before they become overtly symptomatic—can prevent hospitalizations and serious complications. The FDA has already approved TAVR for certain patients without symptoms, and Medicare beneficiaries should not be left behind by outdated coverage rules.

Delays in care harm patients
Current coverage and program requirements can slow care for patients who already face complex diagnostic and referral processes. These delays are not administrative inconveniences—they translate into real harm. Patients waiting for TAVR experience preventable hospitalizations, avoidable deaths, and higher overall costs to the healthcare system. Medicare policy should remove unnecessary hurdles that delay treatment without improving safety.

Access to care is an equity issue
Restrictive site and volume requirements disproportionately affect patients who live farther from large academic centers, including many seniors and lower-income patients in Arizona and surrounding regions. Requiring long travel for care creates barriers that are especially hard on frail patients and caregivers. Evidence shows that concentrating care at higher-volume centers does not improve short-term outcomes, but it does make access harder. Expanding the number of hospitals that can safely provide TAVR improves access without sacrificing quality.

Quality should be judged by outcomes, not outdated rules
TAVR is no longer a new or experimental therapy. Outcomes are tracked nationally, publicly reported, and closely monitored. CMS has effective tools to identify quality concerns and intervene when needed. Continued Coverage with Evidence Development is no longer necessary for routine, FDA-approved TAVR procedures and now functions primarily as a barrier to care rather than a safeguard.

Request to CMS
I respectfully urge CMS to:

Expand coverage to include appropriately selected patients with severe aortic stenosis, including those without clear symptoms;

End Coverage with Evidence Development for FDA-approved TAVR indications; and

Shift from rigid structural and volume requirements to outcomes-based quality oversight.

Modernizing NCD 20.32 would allow clinicians to intervene earlier, reduce preventable harm, and ensure that Medicare beneficiaries—regardless of where they live—can access timely, high-quality care.

Thank you for the opportunity to comment and for your commitment to policies that put patients first.

Respectfully,

Abhishek Sawant, MD
Lifetime Heart and Vascular
Chandler, Arizona

Less

To the National Coverage Database/CMS:

I am writing to advocate for a necessary update to the current National Coverage Determination for Transcatheter Aortic Valve Replacement (TAVR). Specifically, I recommend that CMS eliminate the requirement for an independent, face-to-face evaluation by a cardiac surgeon prior to the procedure, and remove the mandate for a surgeon’s physical presence during uncomplicated percutaneous TAVR implantations.

1. Consistency with Established Percutaneous Standards
The current TAVR evaluation mandate is an outlier in modern interventional cardiology. In Percutaneous Coronary Intervention (PCI)—a procedure of similar complexity and risk—interventional cardiologists use their clinical judgment to determine when a surgical consultation (for CABG) is necessary. TAVR has matured into a standard-of-care, percutaneous procedure. Requiring a surgical "gatekeeper" for every case—regardless of the patient's low surgical risk or clear suitability for a transcatheter approach—creates a double standard that does not exist for other catheter-based structural or coronary interventions.

2. Streamlining Patient Care and Access
The requirement for a face-to-face surgical evaluation acts as a significant bottleneck.

Delays in Care: Appropriately selected patients often wait weeks for an office visit with a surgeon whose services they will not utilize. This "pre-authorization" step can lead to clinical decompensation in patients with severe symptomatic aortic stenosis.
Health Equity: Patients in rural or underserved areas often face additional travel and financial burdens to meet a surgeon for a consultation that is frequently a formality in the current "TAVR-first" era.
3. Resource Optimization and Cost Reduction
The mandate for a surgeon to be in the room during a percutaneous TAVR is a sub-optimal use of highly specialized medical resources.

Surgeon Productivity: Modern TAVR is almost exclusively transfemoral and percutaneous. Forcing a surgeon to be present for these routine cases prevents them from performing open-heart surgeries where their expertise is truly required.
Systemic Cost: Reducing the mandatory "two-physician" requirement for the duration of the procedure would significantly lower the procedural cost to the Medicare program without compromising safety, provided that a surgical team remains available on-site for emergencies.
4. Conclusion
The "Heart Team" concept has been vital to the success of TAVR, and interventionalists should continue to collaborate with their surgical colleagues. However, the mandated surgical evaluation and intra-operative presence have become administrative hurdles rather than clinical safeguards. Aligning TAVR regulations with PCI standards will expedite patient care, reduce costs, and allow physicians to exercise the professional judgment for which they are trained.

I urge CMS to revise NCD 20.32 to reflect these modern clinical realities.

Respectfully

Dr Augustin DeLago Jr MD

Less

[PHI Redacted] I do have strong opinions on this matter. I am also an engineer and look at the issue through those eyes. The main concern for me is what is considered a symptom? Just because someone is not getting out of breath going up some stairs does not mean they are asymptomatic. Are they experiencing thickening of the heart walls therefore reducing the blood volume being delivered to the body and causing the heart to work harder? Is this considered a symptom?

To reduce my thoughts to a cogent statement. I believe the guidelines should facilitate patient input into the decisioning. [PHI Redacted] I do recognize that cardiologists have specialized training, but they should not be the sole decision makers.

Please allow the guidelines to facilitate TAVR with patient input.

Less

Recommendations for NCD Reconsideration

Change the requirement for two providers performing the procedure based on site choice to allow flexibility and improve access.
The current restrictive NCD requiring both a CT surgeon and an IC is a barrier to care, as it limits when and where cases can be performed.
Open up indications for TAVR beyond the current limitations, eliminating language stating that the patient must be symptomatic, as emerging evidence supports benefit in asymptomatic patients.

Less

1. The evidence describing the role of TAVR for AS in symptomatic and asymptomatic patients:
The role of TAVR in symptomatic AS patients is well established. Partner trials conclusively proved benefits in high, intermediate and low risk AS patients. In my personal experience this procedure is very effective, causes much less morbidity than open heart surgery and patients have better long-term quality of life vs SAVR. Even older active patients can reap the benefits as well.
We know that pathophysiologic changes in left ventricle and other cardiac structures with severe AS start much earlier than when symptoms happen and some of these might be irreversible. Early TAVR trial has confirmed the benefit of TAVR in asymptomatic severe AS patients.

2. The importance of TAVR as a reasonable and necessary service for Medicare beneficiaries (supported by evidence):
Majority of severe AS patients are in Medicare age. It is certainly reasonable and necessary based on multiple trials. One thing that is sometimes not clear in clinical trials is the speed of recovery and better overall activity level of patients post TAVR vs SAVR that we see in clinical practice.

3. Your experience of the current NCD as it relates to patient access and any issues that should be addressed in an updated coverage policy:
With the current 3rd generation TAVR devices, need for patient needing emergent open-heart surgery is miniscule. In my experience, we likely still need the CT surgeon as part of multidisciplinary team to evaluate patient in the clinic. But we don’t need the CT surgeon in the operating room. This will improve patient access as scheduling can be simpler.

Less

Centers for Medicare & Medicaid Services (CMS)
Coverage and Analysis Group

Dear CMS Coverage and Analysis Group,

I am writing as a healthcare executive responsible for ensuring timely, high-quality cardiovascular care for diverse communities—including rural residents, low-income seniors, and historically underserved populations. I appreciate CMS opening this National Coverage Analysis focused on TAVR for aortic stenosis (AS), including both symptomatic and asymptomatic patients, and for explicitly requesting peer-reviewed scientific evidence to inform the reconsideration. ([Centers for Medicare & Medicaid Services][1])

I write to support the requestor’s position (Edwards Lifesciences) that CMS should modernize NCD 20.32 by: (1) expanding coverage to include eligible asymptomatic severe AS patients, (2) sunsetting Coverage with Evidence Development (CED) for TAVR, and (3) removing outdated, burdensome requirements that function as access barriers, while maintaining appropriate safeguards and quality accountability. ([Centers for Medicare & Medicaid Services][2])

1) Expand coverage to include appropriate asymptomatic severe AS patients—evidence now supports earlier intervention

The clinical reality in our communities is that “asymptomatic” status can be difficult to verify, and symptom development can be sudden. From a system perspective, waiting for clinical decline is often a pathway to emergency presentations, avoidable hospitalizations, and worse outcomes.

New randomized evidence supports an “early TAVR” strategy in asymptomatic severe AS. In the EARLY TAVR trial, early TAVR reduced the composite endpoint of death, stroke, or unplanned cardiovascular hospitalization compared with clinical surveillance (26.8% vs. 45.3%; hazard ratio 0.50; 95% CI 0.40–0.63). ([Ovid][3])

Additionally, Edwards reports FDA approval of its SAPIEN 3 platform for severe AS patients without symptoms (first approval for TAVR in asymptomatic patients), based on EARLY TAVR evidence. Coverage policy should keep pace with this evolution so Medicare beneficiaries can access timely, evidence-supported care. ([ir.edwards.com][4])

Request to CMS: Update NCD 20.32 to cover TAVR for appropriately selected asymptomatic severe AS patients consistent with contemporary evidence and FDA-approved indications. ([Centers for Medicare & Medicaid Services][2])

2) Reduce avoidable delays and downstream harm—current administrative and structural requirements can slow care

In our operations, the most harmful “barriers” are the ones that delay care for patients already moving through complex diagnostic and referral pathways. Evidence summarized in the requestor letter highlights that TAVR patients have longer time from diagnosis to treatment than SAVR patients (median 157 vs. 98 days). Among symptomatic severe AS patients referred for TAVR, approximately 25% waited more than 10 weeks; the consequences included substantial waiting-list mortality (3.8% at 1 month; 10.4% at 3 months). ([Centers for Medicare & Medicaid Services][2])

Delays also increase total cost of care: a one-year wait for TAVR was associated with $10,080 in excess total costs in one analysis summarized by the requestor. ([Centers for Medicare & Medicaid Services][2])

Request to CMS: Streamline coverage requirements so that Medicare beneficiaries are not harmed by avoidable delays created by overly prescriptive structural mandates that are not clearly tied to better outcomes in contemporary practice. ([Centers for Medicare & Medicaid Services][2])

3) Advance health equity—volume thresholds and restrictive site policies can worsen geographic disparities

Access is not just a clinical issue; it is an equity issue. The requestor letter summarizes evidence that rural communities have a high proportion of adults aged 65+, yet the majority of TAVRs occur at urban sites—limiting access to both procedural and post-procedural care. ([Centers for Medicare & Medicaid Services][2])

Critically, evidence summarized by the requestor indicates that applying a volume threshold that shifts care to the nearest higher-volume site did not improve predicted 30-day outcomes but increased driving time by up to 88 minutes for rural patients—a material barrier for frail seniors and low-income patients. ([Centers for Medicare & Medicaid Services][2])

The same requestor summary also reports that access becomes more equitable as more hospitals offer TAVR (a 30% increase in TAVR hospitals from 2016 to 2019 occurred alongside a 31% decrease in procedure access inequality). ([Centers for Medicare & Medicaid Services][2])

From the perspective of a health system accountable to community benefit and population health, we should be moving policy toward measured outcomes and transparent quality, not blunt restrictions that concentrate care and inadvertently widen disparities.

Request to CMS: Reassess volume-based site restrictions and replace them with a model that protects quality without worsening geographic and socioeconomic disparities. ([Centers for Medicare & Medicaid Services][2])

4) Sunset CED for TAVR—consistent with CMS’s own CED principles and the maturity of the evidence base

CMS’s current NCD framework includes participation in a national audited registry and other CED-related requirements. ([Centers for Medicare & Medicaid Services][1]) However, CMS’s CED guidance states that an NCD requiring CED “should [not] last indefinitely” and that coverage under CED should be time-limited to support timely generation of sufficient evidence to inform patient/clinician decision-making and enable a reasonable-and-necessary determination.

The requestor asserts that evidentiary gaps have been addressed and that TAVR has matured substantially since earlier iterations of the NCD, including the availability of direct measures of quality and robust outcomes data. ([Centers for Medicare & Medicaid Services][2])

Request to CMS: Remove CED as a condition of coverage for TAVR when performed for FDA-approved indications in appropriately selected patients, while maintaining an outcomes-driven quality framework. ([Centers for Medicare & Medicaid Services][2])

5) Modernize quality oversight—shift from structural mandates to outcomes-based accountability

If CMS’s goal is to ensure quality, the strongest approach is to measure quality directly and transparently. The requestor letter notes that a 30-day TAVR composite quality measure is now available, is publicly reported, and is designed to identify site-level deficiencies; it describes the measure as benchmarking outcomes across endpoints including death, stroke, bleeding, AKI, and paravalvular regurgitation using registry data over a rolling timeframe. ([Centers for Medicare & Medicaid Services][2])

This is directionally aligned with how high-performing systems drive improvement: standardize clinical pathways, measure outcomes, audit performance, and intervene when results fall outside expected ranges.

Request to CMS: Maintain patient safeguards (Heart Team evaluation, shared decision-making, appropriate patient selection) while enabling broader access by emphasizing measured outcomes, registry-based surveillance, and transparent quality reporting rather than rigid program prerequisites and volume thresholds. ([Centers for Medicare & Medicaid Services][2])

Closing

On behalf of the communities we serve, I urge CMS to use this NCA to modernize NCD 20.32 in a way that protects quality while expanding equitable access:

1. cover appropriate asymptomatic severe AS patients,
2. sunset CED for routine FDA-approved indications, and
3. remove outdated requirements that delay care and exacerbate disparities. ([Centers for Medicare & Medicaid Services][2])

Thank you for the opportunity to comment and for CMS’s commitment to evidence-based coverage policy that improves outcomes for Medicare beneficiaries.

Respectfully,
Gordon Wesley, DBA, FACHE
UChicago Medicine AdventHealth
gordon.wesley@adventhealth.com

[1]: https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=321 "NCA - Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2) - Tracking Sheet"
[2]: https://www.cms.gov/files/document/id321.pdf "Requestor letter"
[3]: https://www.ovid.com/journals/nejm/pdf/10.1056/nejmoa2405880~transcatheter-aortic-valve-replacement-for-asymptomatic?utm_source=chatgpt.com "Transcatheter Aortic-Valve Replacement for... : New England Journal of Medicine"
[4]: https://ir.edwards.com/news/news-details/2025/Edwards-TAVR-Receives-FDA-Approval-for-Patients-With-Asymptomatic-Severe-Aortic-Stenosis/?utm_source=chatgpt.com "Edwards Lifesciences Corp - Edwards TAVR Receives FDA Approval for Patients With Asymptomatic Severe Aortic Stenosis"

Less

Coordinating scheduling these cases with a CT surgeon has been difficult and has delayed patient care more often than we would have liked. We currently only have 1 CT surgeon and when he is busy doing a surgery or on vacation, it impacts our ability to do TAVR. There are increased wait times with trying to coordinate schedules across multiple specialized teams, which extends times from referral to procedure. Extended wait times can negatively impact patient outcomes, increasing mortality and hospitalizations.

Less

From my perspective, I have seen the benefits our TAVR program has brought to our patients. The drastic lifestyle improvements that can be achieved through a minimally invasive procedure and at times a single night hospital stay are amazing. My only frustration is some of the barriers imposed on the program that can at times limit our access. Requiring 2 CT surgeons and a fairly high annual case volume can be difficult for rural hospitals that are the only access to interventional care for a large population of people. CT surgeon availability is an issue across the country for all organizations and requiring 2 to be on staff drastically impacts smaller hospitals the most. Even if their quality and outcomes are good.

Less

TAVR has been transformative for a large number of patients. The NCD is in its current form os restricting access for some critical groups of patients:
1. Small hospital with inadequate CT surgery support
2. Rural hospitals with no CT surgery backup
3.Asymptomatic severe AS patients
Today patients who see a CT surgeon as opposed to a heart team are not required to get a heart team condult for surgical AVR.

The new NCD must require all patients needing an aortic valve replacement at any age to have a heart team evaluation( in person or remote)
Mandatory second operator billing is no longer relevant and not needed.
Data clearly supports TAVR in patients with severe asmyptomatic severe aortic stenosis.
CED status and mandatory registry must be streamlined to reduce the burden on reporting hospitals.
All aortic valve replacement ( surgical and transcatheter) should be included in the CMS TEAM initiative to manage global cost and maintain quality.

Less

I would like to comment on the consideration of updating the NCD on the indications for TAVR. TAVR has proven to be an acceptable alternative to surgical AVR in all patients, including those at a low risk for surgical AVR. Current guidelines find it acceptable to perform a surgical AVR for patients with asymptomatic aortic valve stenosis. It stands to reason that patients would receive a similar clinical benefit of TAVR, rather than waiting until the meet an arbitrary definition of symptomatic. Furthermore, current literature, such as the EARLY TAVR study confirms that patients derive clinical benefit by proceeding with TAVR, when aortic stenosis is deemed severe, rather than waiting until they report symptoms. As a TAVR operator and interventional cardiologist in practice for almost 12 years, I can attest that many patients do not believe themselves to be symptomatic, even when they clearly are. This presents a dangerous scenario for some, as the presenting complication for some patients with severe aortic valve stenosis may be sudden cardiac death. I urge CMS to update the NCD for TAVR to include "asymptomatic patients with severe aortic valve stenosis.

Less

I am writing to provide public comment on the National Coverage Analysis (NCA) for Transcatheter Aortic Valve Replacement (TAVR) in patients with aortic stenosis (CAG-00430R2). As an interventional cardiologist with extensive experience in complex coronary and structural heart interventions, I strongly support expanding TAVR coverage and eliminating outdated regulatory barriers that currently restrict patient access to this life-saving therapy.

I. Coverage for Asymptomatic Patients

I strongly support expanding TAVR coverage to include asymptomatic patients with severe aortic stenosis. The clinical evidence overwhelmingly demonstrates clear benefit in treating these patients before symptom onset and irreversible cardiac damage occurs.

The landmark EARLY TAVR trial, published in the New England Journal of Medicine, randomized 901 patients with asymptomatic severe aortic stenosis to early TAVR versus clinical surveillance.¹ The results were striking: the primary composite endpoint of death, stroke, or unplanned cardiovascular hospitalization occurred in 26.8% of the TAVR group compared to 45.3% in the surveillance group (HR 0.50; 95% CI 0.40-0.63; P<0.001). This represents a 50% relative risk reduction with early intervention.

Importantly, 87% of patients in the clinical surveillance group ultimately required aortic valve replacement during follow-up, with 39.2% presenting with acute valve syndrome—a finding associated with significantly worse outcomes including higher rates of stroke.² These data demonstrate that waiting for symptoms exposes patients to unnecessary risk of catastrophic events.

A recent systematic review and meta-analysis of randomized controlled trials confirms that early aortic valve replacement in asymptomatic patients reduces all-cause mortality by 55% (HR 0.45; 95% CI 0.24-0.86) and heart failure hospitalization by 79% (HR 0.21; 95% CI 0.05-0.96).^3,4

Recommendation: Coverage should be approved for asymptomatic severe aortic stenosis without additional burdensome requirements beyond standard clinical judgment and heart team evaluation. The evidence is clear that early intervention saves lives.

II. Elimination of Hospital and Operator Volume Requirements

The current hospital and operator volume requirements should be eliminated or substantially revised. These mandates were established during TAVR's early adoption phase in 2012 and no longer reflect the maturity of the procedure, the evolution of device technology, or the capabilities of today's interventional cardiologists.

A. Evidence on Volume-Outcome Relationships

While historical data showed volume-outcome relationships for TAVR, these findings must be interpreted in context.^5,6 The New England Journal of Medicine analysis by Vemulapalli et al. found that while lower-volume hospitals had somewhat higher and more variable 30-day mortality rates, the absolute difference between the lowest and highest volume quartiles was modest (3.19% vs 2.66%).⁵ This difference has narrowed substantially with improved devices and techniques.

Critically, research has shown that SAVR volume alone is not associated with better TAVR outcomes—it is TAVR experience specifically that matters.⁷ The 2018 JAMA Cardiology analysis found that "hospital SAVR volume alone is not associated with better TAVR outcomes." This finding undermines the rationale for SAVR volume thresholds as a TAVR program requirement.

B. Access Disparities Created by Volume Requirements

Volume thresholds create significant access barriers, particularly for rural and underserved communities. Studies have documented that:

1. Patients in low-population-density areas face significantly longer travel distances (mean additional distance of 43.5 miles) and lower TAVR utilization rates with a 7-fold difference between lowest and highest population density regions.⁸

2. Geographic and socioeconomic barriers significantly impact TAVR access, with areas featuring higher deprivation indices having lower TAVR utilization rates.⁹

3. Approximately 91% of TAVR patients in the United States are White, reflecting systematic access disparities that volume requirements may exacerbate.¹⁰

4. Hospital adoption of TAVR programs has been concentrated in metropolitan areas serving higher-income populations, leaving underserved communities behind.¹¹

C. Interventional Cardiologist Competency

Interventional cardiologists who perform complex coronary interventions—including chronic total occlusion (CTO) procedures, high-risk PCI with mechanical circulatory support, and other advanced catheter-based therapies—possess the technical expertise, wire skills, and clinical judgment necessary to safely perform TAVR. The 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology recognizes that coronary intervention competencies serve as the foundation for structural heart interventions.¹²

TAVR has evolved into a well-established procedure with a transfemoral approach used in over 84% of cases.⁵ The technical demands of contemporary TAVR—particularly for straightforward transfemoral cases—are well within the capabilities of experienced interventional cardiologists. SCAI has published expert consensus statements providing guidance on alternative access routes and best practices that further expand the pool of qualified operators.¹³

Recommendation: Eliminate arbitrary volume thresholds that restrict patient access without evidence of improved outcomes. Instead, focus on competency-based assessment, quality metrics, and participation in national registries such as the STS/ACC TVT Registry. Qualified interventional cardiologists with documented training and competency in structural heart procedures should be permitted to perform TAVR regardless of institutional volume.

III. Registry Data Collection

While continued participation in the STS/ACC TVT Registry provides valuable real-world data, registry participation should not be used as a barrier to coverage. The evidence base for TAVR is now robust, with multiple randomized controlled trials demonstrating safety and efficacy across all surgical risk categories. Registry data should serve quality improvement purposes rather than function as ongoing "coverage with evidence development."

IV. Conclusion

TAVR has matured into a safe, effective, and well-established treatment for aortic stenosis. Coverage policy should reflect this reality by:

5. Approving coverage for asymptomatic patients with severe aortic stenosis

6. Eliminating outdated institutional volume requirements that limit patient access

7. Recognizing that qualified interventional cardiologists with expertise in complex coronary and structural procedures have the skills necessary to perform TAVR safely

Patients with aortic stenosis deserve timely access to proven, life-saving therapy regardless of where they live or the volume of their local hospital. I urge CMS to update coverage policy to reflect the current evidence and expand access to this essential intervention.

Thank you for the opportunity to provide comment on this important matter.

Respectfully submitted,

Sridevi Pitta
Sridevi Reddy Pitta, MD, MBA, FACC, FSCAI, RPVI
Professor of Medicine, Department of Internal Medicine
Anne-Brunette School of Medicine, Texas Christian University, Fort Worth, TX 76129
Interventional Cardiologist, Texas Health Presbyterian Hospital Denton
Chair, Quality Assurance and Performance Improvement Committee
Medical Executive Committee, Texas Health Presbyterian Hospital Denton
Strategic Advisory Board, Heart and Vascular Service Line Strategy, Texas Health Resources
Medical Director, Cardiology Service Line, Texas Health Presbyterian Hospital Denton
Core Faculty, Internal Medicine Residency Program Texas Health Resources HEB/Denton
SrideviRPitta@TexasHealth.org; Sridevi.Pitta@tcu.edu

References

1. Généreux P, Schwartz A, Oldemeyer JB, et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2024;391(22):2065-2075. doi:10.1056/NEJMoa2405023. PMID: 39466903
2. Généreux P, Schwartz A, Oldemeyer JB, et al. Outcomes of Early vs Delayed Aortic Valve Replacement: Analysis of the EARLY TAVR Valve Implant Population. J Am Coll Cardiol. 2025. doi:10.1016/j.jacc.2025.08.045. PMID: 41297989
3. Khalil M, Altibi AM, et al. Management of asymptomatic severe aortic stenosis: a systematic review and meta-analysis. Open Heart. 2022;9(1):e001962. doi:10.1136/openhrt-2022-001962. PMID: 35504668
4. Aortic Valve Replacement vs Clinical Surveillance in Asymptomatic Severe Aortic Stenosis: A Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2025;85(3):243-256. doi:10.1016/j.jacc.2024.11.006
5. Vemulapalli S, Carroll JD, Mack MJ, et al. Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement. N Engl J Med. 2019;380(26):2541-2550. doi:10.1056/NEJMsa1901109. PMID: 30946551
6. Khera S, Kolte D, Gupta T, et al. Volume-outcome relationships for transcatheter aortic valve replacement-risk-adjusted and volume stratified analysis of TAVR outcomes. Cardiovasc Revasc Med. 2018;19(3 Pt B):391-397. PMID: 29174245
7. Mao J, Redberg RF, Carroll JD, et al. Association Between Hospital Surgical Aortic Valve Replacement Volume and Transcatheter Aortic Valve Replacement Outcomes. JAMA Cardiol. 2018;3(11):1070-1078. doi:10.1001/jamacardio.2018.3562. PMID: 30383143
8. Cholack G, Goel SS, et al. Transcatheter Aortic Valve Replacement in Low-Population Density Areas: Assessing Healthcare Access for Older Adults With Severe Aortic Stenosis. Circ Cardiovasc Qual Outcomes. 2020;13(9):e006245. PMID: 32813564
9. No-Transcatheter Aortic Valve Replacement (TAVR) Zones and Their Effect on Access to Care for Medicare Beneficiaries with Aortic Stenosis. Adv Ther. 2025. doi:10.1007/s12325-025-03116-8
10. Mehta SD, Reddy KP, Giri JS, Nathan AS. The Scope of Racial, Ethnic, and Socioeconomic Disparities in TAVR Access and Proposed Solutions. Cardiac Interventions Today. 2024;Sept/Oct.
11. Nathan AS, Yang L, et al. Racial, Ethnic, and Socioeconomic Disparities in Access to Transcatheter Aortic Valve Replacement Within Major Metropolitan Areas. JAMA Cardiol. 2022;7(2):150-158. doi:10.1001/jamacardio.2021.4641. PMID: 34787638
12. 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions). Circ Cardiovasc Interv. 2023;16(2):e000088. doi:10.1161/HCV.0000000000000088
13. SCAI Expert Consensus Statement on Alternative Access for Transcatheter Aortic Valve Replacement. J Soc Cardiovasc Angiogr Interv. 2024. Society for Cardiovascular Angiography and Interventions.

Less

I am thankful for the opportunity to provide a comment during the CMS open comment period regarding the TAVR national coverage decision. It's an opportunity to reflect on how far TAVR has come since its early inception and to consider where it may be going. As someone who has participated in TAVR procedures since their initiation in the United States, I can attest to the meaningful changes in technology, technique and process that have occurred over the last 15 years. With that insight, I feel it is important to recognize that TAVR remains a complex and radically life-changing procedure for our patients with one of the strongest therapeutic evidence-bases available in modern medicine. It is also important to recognize that multiple pieces of data have come forward to corroborate what practicing experts in this space already know. Namely:

A) conversion to open heart surgery in the process of TAVR is extremely rare at ~ 0.5% (European Journal of Cardio-Thoracic Surgery. 2025. McGrath D, Sun C, Zhu M, et al) and in line with rates for other catheter-based procedures that do not require surgical backup (Journal of the American College of Cardiology. 2005. Yang EH, Gumina RJ, Lennon RJ, et al.)

B) Prolonged wait times for TAVR are associated with increased mortality and heart failure hospitalizations. During the reported average 80-day wait period for TAVR, the cumulative probability of wait-list mortality is approximately 2%, with heart failure hospitalization occurring in about 12% of patients (Circulation. 2018. Elbaz-Greener G, Masih S, Fang J, et al.)

C) Wait times for TAVR are substantially longer than for SAVR (Circulation. Cardiovascular Interventions. 2020. Albassam O, Henning KA, Qiu F, et al.) presumably due to the multidisciplinary pathway of the evaluation and treatment process since the since procedural space and hospital room occupancy requirements for TAVR are otherwise less cumbersome.

D) relaxation of the NCD during the COVID pandemic provided a social experiment as to the safety and efficacy of TAVR in the absence of a multidisciplinary treatment team. This experiment demonstrated no ill effects on 30-day mortality (Am J Cardiol. 2021 Apr 15:145:97-101.doi: 10.1016/j.amjcard.2020.12.086).

E) the inconsistency in requirements for proceeding to AVR where surgeons may make decisions about moving forward without the input of structural or imaging cardiologists but structural cardiologists may not, undermines even the concept of a multidisciplinary team of experts. It was plausible to understand these asymmetric regulations in the early days of TAVR when cardiologists brought little direct experience to the AVR process beyond balloon aortic valvuloplasty, but TAVR volumes have since surpassed SAVR volumes (The Journal of the American Medical Association. 2021. Davidson LJ, Davidson CJ.) and Structural Heart physicians now bring a wealth of experience to the table that undermines this argument. In the current environment, all valve experts are equal but some are seemingly more equal than others.

Based on these data, I feel it is very reasonable to remove the multidisciplinary requirements from the TAVR NCD in an effort to improve throughput and access to care for patients. I personally believe that TAVR-performing hospitals should continue to have surgical capacity and that heart teams should continue to be encouraged, though not mandated. Well-functioning multidisciplinary teams can be enriching and of great value when all members are motivated and committed. I count a number of engaged and thoughtful structural surgeons among my closest and most respected friends and value them tremendously. On the other hand, pro-forma multidisciplinary teams can be viewed as a burden solely required to satisfy regulations. When team members view the partnership only as an obligation, the resultant effect create unnecessary delays for patients, frustration for staff, and may play a role in physician burnout (PloS One. 2021. Werdecker L, Esch T.) Thus, while multidisciplinary care should be encouraged and will continue to be a vibrant part of the TAVR landscape, particularly in hospitals with well cultivated heart teams, it should no longer be a requirement in the evaluation or treatment process. Forcing disinterested and uncommitted partnerships does not provide value and the data listed above make clear that multidisciplinary teams are no longer required for effective patient care. In fact, transitioning away from a mandated multidisciplinary environment may provide the motivation required for all disciplines to invest in the Heart Team concept in a healthy and effective manner once there is recognition that a seat at the table is not otherwise guaranteed.

Thank you for your consideration.

James McCabe MD
Director of Structural Heart
Beth Israel Deaconess Hospital

Less

Dear CMS,

Two items I would like for you all to consider potentially changing:

1. Continuing to require the a cardiothoracic surgeon to be in the room during this procedure seems overburden some, costly, and not necessary. I think this would be a reasonable change.

2. I also do wonder if the continued need for a cardiothoracic surgeon to evaluate a pre-TAVR. I do agree that shared decision-making is very important, and I suppose this requirement continues to mandate it. However, for straightforward patient, over 80 years old, for example, this does seem unnecessary and costly.

Thank you for your time and consideration.

Sincerely,
John

Less

1) Whether asymptomatic patients should be approved for TAVR? Yes. The evidence from EARLY TAVR is in support of this indication expansion.
2) Whether ongoing registry data should be collected for TAVR? I think mandatory registry participation has elevated the field, and I will support efforts to continue this.
3) Whether hospital and operator volume requirements should remain? I think the current operator and institutional requirements are outdated and need to change to reflect advancements in technology and procedural technique. The requirement to have 2 co-operators (1 IC and1 Surgeon) needs to evolve to single operator with surgical back up in the building. Also, the requirement to see a surgeon prior to TAVR needs to be removed. A 55-year-old patient with bicuspid AS can see a surgeon on Monday and get SAVR on Tuesday whereas a 90-year-old patient with calcific AS can see an IC on Monday and won’t get a TAVR until a surgeon agrees this TAVR procedure is appropriate. Depending on the healthcare system that can take days, weeks or months. We need to move away from the gatekeeper concept to elective consults dictated by clinical needs.

Less

1) Expansion of TAVR Indications to Asymptomatic Patients
Sufficient clinical evidence supports the use of transcatheter aortic valve replacement (TAVR) in patients with asymptomatic severe aortic stenosis. I recommend approval for coverage in this population, given the demonstrated benefits in reducing morbidity and mortality.

2)Elimination of Mandatory Ongoing Registry Data Collection
The established safety profile of TAVR renders continued mandatory registry data collection unnecessary. Discontinuing this requirement would alleviate administrative burdens and reduce associated costs for healthcare systems.

3)Removal of Hospital and Operator Volume Restrictions
Volume-based restrictions for hospitals and operators should be eliminated to improve patient access, particularly for those requiring extensive travel. TAVR has achieved a mature safety profile comparable to that of percutaneous coronary intervention (PCI), which transitioned from being limited to high-volume centers with on-site cardiac surgery to broader availability, including rural and outpatient settings.

4)Revision of Pre-Procedural and Intra-Procedural Specialist Requirements
Current guidelines clearly delineate indications for TAVR and surgical aortic valve replacement (SAVR), rendering mandatory evaluation by both an interventional cardiologist and a cardiac surgeon redundant. I recommend modifying this requirement to permit evaluation by either specialist alone, which would suffice for insurance approval.
Similarly, for the procedure itself, the presence of both specialists is unnecessary in routine cases; a single qualified operator is adequate, analogous to mitral transcatheter edge-to-edge repair (M-TEER). Provision should be retained for involving both specialists when alternate access routes or surgical cut-downs are required.

Less

PCI Requirement:
The current PCI requirement of >/= 300 PCI’s per year for both new and existing TAVR centers is both outdated and no longer clinically relevant. With PCI volumes nationwide continuing to decline due to improved primary and secondary prevention measures, as well as continued growth in the number of PCI centers, primarily in more urban and metropolitan areas (many of which do not have a Certificate of Need as a requirement), maintaining a requirement of >/= 300 PCI’s per year is no longer realistic. In addition, high PCI volume does not translate to TAVR experience or high quality outcomes, and vice versa. I would propose that the PCI requirement for existing TAVR centers be removed and that the PCI requirement for new TAVR centers be appropriately reduced (i.e., >/=150 PCI in the year prior to approval). Furthermore in areas where one group of physicians serves multiple hospitals in the same healthcare system/network, the volume requirement should be the sum total of procedures performed across all facilities (and not just the facility where TAVR is performed), as overall PCI experience of the individual operator encompasses all sites and not just one.

Two operator requirement:
With continued evolution of TAVR devices (resulting in the vast majority of procedures being performed in a percutaneous transfemoral approach) as well as the wealth of experienced gained over the last decade plus of CMS approval for TAVR, one could argue that the mandated two operator participation of one IC and one CTS is outdated. Furthermore, at experienced TAVR centers, the nationwide incidence of emergent conversion to surgery at the time of TAVR is negligible to the point where requiring a CTS presence for “emergency back-up” in routine TAVR cases is truly not necessary. A better approach would be to remove the mandatory two operator requirement for existing TAVR centers and instead make the concomitant participation of an IC and CTS in a TAVR procedure to be determined by an experienced Heart Team (e.g., cases with alternative access, high risk for complications, etc.). In the vast majority of uncomplicated transfemoral approach TAVR procedures, and especially in procedures in prohibitive risk surgical patients who are non-salvage, the mandatory requirement for CTS participation in the procedure is unwarranted. For new centers, however, there is tremendous value in both an IC an CTS participating in TAVR procedures, and so I would propose that for new centers, two operators be mandated until adequate TAVR experience at the center is achieved (i.e., >/=200 TAVR cases).

Less

I am in support of National coverage for symptomatic and asymptomatic patients with clinically significant /severe Aortic stenosis being approved for TAVR.
There has been a large amount of clinical data showing mortality and morbidity benefits.

—I’m ok with ongoing registry data collection for TAVR

Hospital and operator volume requirements should not remain for TAVR- once a physician is credentialed for the procedure, the pressure to keep up numbers is not the correct way to practice.

Less

Suggested Recommendations

1) Expand TAVR Coverage
Expand TAVR coverage to include all patients, regardless of symptom status (both symptomatic and asymptomatic), when clinically appropriate.

2) Mandate Multidisciplinary Team (MDT) Review for All AVR Cases
Require documented review of every aortic valve replacement (AVR)—including both TAVR and SAVR—within a formal multidisciplinary heart team discussion.
This review must include a cardiac surgeon and involve joint evaluation of echocardiography and CT anatomy.
The purpose is to ensure appropriate triage between TAVR and SAVR based on anatomical and clinical risk.
While a separate surgical consultation may not be required, the presence and active participation of a cardiac surgeon in the MDT review is essential to minimize anatomical misclassification and avoid suboptimal outcomes.

3) Maintain a Two-Operator Requirement for TAVR
Continue to mandate two qualified operators for every TAVR procedure to ensure procedural safety.
Acceptable operator combinations include:
Two interventional cardiologists (IC/IC)
Two cardiac surgeons (CS/CS)
One interventional cardiologist and one cardiac surgeon (IC/CS)

Thank you

Less

Thank you for the opportunity to comment on the contemporary use of TAVR in clinical practice. I have eight years of experience as a practicing interventional cardiologist, with comprehensive exposure to contemporary coronary, structural, and peripheral interventions. In my role as Cath Lab Director at ACC-accredited regional referral hospitals in Colorado Springs with active structural and PCI programs with annual volumes exceeding 500 structural procedures and 500 coronary revascularization procedures. I am directly responsible for procedural quality, program development, and outcomes oversight, providing firsthand insight into evidence-based practice standards and real-world implementation. In addition, my prior academic and research background includes authorship on more than 30 peer-reviewed publications, supporting my ability to critically evaluate clinical trial data, registry evidence, and evolving guideline recommendations relevant to these discussions.

1. Evidence for TAVR in Asymptomatic Severe Aortic Stenosis

Management of asymptomatic severe aortic stenosis (AS) has traditionally favored watchful waiting until symptom onset, left ventricular (LV) dysfunction, or high-risk features emerged. However, randomized evidence over the past decade has challenged this paradigm by demonstrating that early valve intervention improves clinical outcomes.

The RECOVERY trial randomized asymptomatic patients with very severe AS to early surgical aortic valve replacement (SAVR) versus conservative care and demonstrated a significant reduction in all-cause mortality and sudden cardiac death with early surgery.¹ Similarly, the AVATAR trial showed that early SAVR in asymptomatic severe AS significantly reduced the composite of death, myocardial infarction, stroke, or heart failure hospitalization compared with watchful waiting.² Together, these trials established the principle that waiting for symptoms may allow irreversible myocardial damage and worse outcomes, even in patients with preserved LV ejection fraction.

Building on this concept, interest has shifted toward transcatheter aortic valve replacement (TAVR) as an earlier intervention strategy, particularly given its excellent safety profile in low-risk populations. Large randomized trials in symptomatic low-risk patients (PARTNER 3, Evolut Low Risk) demonstrated very low rates of death and stroke, rapid recovery, and favorable LV remodeling with TAVR, supporting its feasibility in earlier disease stages.³?⁴

The EARLY TAVR trial directly addressed this question by randomizing patients with asymptomatic severe AS to early TAVR versus guideline-directed clinical surveillance. Early TAVR significantly reduced the composite endpoint of death, stroke, or unplanned cardiovascular hospitalization, with the benefit largely driven by fewer heart failure events and urgent valve interventions, and without excess procedural risk.⁵ These findings support the concept that preemptive TAVR can improve outcomes by intervening before symptom onset and myocardial decompensation.

In summary, randomized data now support early valve replacement in asymptomatic severe AS, and contemporary evidence demonstrates that early TAVR is a safe and effective strategy that improves clinical outcomes compared with watchful waiting in appropriately selected patients. Ongoing follow-up will further clarify long-term durability and optimal patient selection.

Key References

Kang DH, et al. Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis.N Engl J Med. 2020;382:111–119. (RECOVERY)

Banovic M, et al. Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis. Circulation. 2022;145:648–658. (AVATAR)

Mack MJ, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019;380:1695–1705. (PARTNER 3)

Popma JJ, et al. Self-Expanding Transcatheter Aortic-Valve Replacement in Low-Risk Patients. N Engl J Med. 2019;380:1706–1715. (Evolut Low Risk)

Généreux P, et al. Early TAVR Versus Clinical Surveillance in Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2024. (EARLY TAVR)

2. Procedural Volume Considerations for TAVR

Importantly, coronary PCI volume requirements do not correlate with TAVR outcomes and are not supported by contemporary evidence. Analyses from the STS/ACC TVT Registry consistently demonstrate that TAVR outcomes are associated with overall programmatic experience and institutional TAVR volume, rather than individual operator PCI volumes or coronary case mix.

In an analysis of >26,000 TAVR procedures from the TVT Registry, Kumbhani et al. showed that higher institutional TAVR volume was associated with lower in-hospital mortality and complications, whereas operator background or coronary experience was not an independent predictor of outcomes (Kumbhani DJ et al., JACC, 2019).

Vemulapalli et al. demonstrated that center experience and participation in structured heart team programs, rather than legacy interventional volumes, drove improvements in TAVR safety and effectiveness over time (Vemulapalli S et al., JAMA, 2019).

An STS/ACC TVT Registry study evaluating operator specialty and training background found no significant differences in mortality, stroke, or vascular complications among TAVR operators with interventional cardiology, cardiothoracic surgery, or shared backgrounds when procedures were performed at experienced centers (Carroll JD et al., Annals of Thoracic Surgery, 2020).

Additional analyses confirm that TAVR is a highly standardized, imaging-driven, protocolized procedure, fundamentally distinct from PCI, and that coronary intervention volumes do not predict transfemoral TAVR proficiency or outcomes (Grover FL et al., JACC, 2017; STS/ACC TVT Registry reports).

In summary, applying PCI volume thresholds to TAVR credentialing or program justification is not evidence-based, does not align with registry data, and does not reflect modern structural heart practice, which emphasizes heart team experience, outcomes tracking, and institutional quality metrics.

Less

Suggested Recommendations

1) Expand TAVR Coverage
Expand TAVR coverage to include all patients, regardless of symptom status (both symptomatic and asymptomatic), when clinically appropriate.

2) Mandate Multidisciplinary Team (MDT) Review for All AVR Cases
Require documented review of every aortic valve replacement (AVR)—including both TAVR and SAVR—within a formal multidisciplinary heart team discussion. This review must include a cardiac surgeon and involve joint evaluation of echocardiography and CT anatomy. The purpose is to ensure appropriate triage between TAVR and SAVR based on anatomical and clinical risk.
While a separate surgical consultation may not be required, the presence and active participation of a cardiac surgeon in the MDT review is essential to minimize anatomical misclassification and avoid suboptimal outcomes.

3) Maintain a Two-Operator Requirement for TAVR
Continue to mandate two qualified operators for every TAVR procedure to ensure procedural safety.
Acceptable operator combinations include:
Two interventional cardiologists (IC/IC)
Two cardiac surgeons (CS/CS)
One interventional cardiologist and one cardiac surgeon (IC/CS)

Thank you.

Less

As a registered nurse with 39 years' experience and managing and coordinating the structural heart space for 14 years, I am responsible for navigating hundreds of patients through the necessary clinical journey to TAVR. My primary and essentially only interest is the patient's timely access to this life saving procedure. Due to requirements of surgical presence during percutaneous transfemoral TAVR, there are delays that have created back logs in access to this care. These backlogs can and do result in readmissions for heart failure as well as death.
During the COVID-19 pandemic, CMS had leniency with this requirement, which did demonstrate that the strict two-operator mandate was not necessary for safety.
As this procedure has evolved, it is my belief it can be performed without the requirement of 2 operator specialty mandate. I feel this would improve access to timely care.

Less

I am one of the coordinators of our TAVR program at UW Health. We have a robust program and are able to serve many patients a year. A limitation we have to getting everyone served is surgeon availability. The need to have a surgeon present is a hinderance and results in case delays and completely cancelled case days. Therefore, this delays patient throughput, delays procedure dates, and lengthens wait times backing up the whole system. My ask would be to eliminate the need for surgeons on procedure days and allow for 2 ICs to be present instead. This would allow us to efficiently serve more patients. This is especially important as the referrals have been increasing, and we will need to continue to add more and more procedures each year. This is a pivotal stopping point that needs to be changed in order to allow for growth. Thank you for your consideration.

Less

Agree with the majority comments as mentioned already. In an effort to minimize redundancy, will highlight the encouraged removal of surgeon requirement in TAVR procedures and separate mandated CT surgery consultation. The multidisciplinary HEART team approach accomplishes the task of balancing pros/cons of patient options for AVR. Requirements should adapt with the times and evolution of therapy, keeping the patient as the highest priority with timely interventions, and these relic mandates are dated often resulting in delays in care.

Less

We appreciate the opportunity to comment on the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR).

Our cardiology-driven program currently performs TAVR procedures with two interventional cardiologists and one cardiothoracic surgeon present and at times assisting. As TAVR technology and operator experience continue to advance, we encourage CMS to consider allowing greater flexibility in procedural staffing models.

Specifically, we recommend permitting facilities the option to staff TAVR procedures with either one interventional cardiologist and one cardiothoracic surgeon or two interventional cardiologists, based on institutional preference and demonstrated outcomes. This flexibility would better reflect contemporary practice patterns while preserving a multidisciplinary, team-based approach and maintaining patient safety.

Thank you for your consideration.

Less

As the MEDCAAC committee is opening the TAVR NCD for revision, Providence Health and Services, comprising 51 hospitals in 7 states, has an active interest in easing restrictions on this life-saving procedure, and thus allowing improved access for all patients with aortic stenosis. Geographical, financial and insurance roadblocks to TAVR would be eased by continued TAVR delivery in current and new centers.

Currently, hospital procedure volumes, including for non-TAVR procedures (e.g., percutaneous coronary intervention [PCI]), are used as criteria to start or maintain TAVR programs. Since electronic medical records and registry data are now easily accessible, direct measures of quality outcomes should be used to permit formation and maintenance of TAVR programs. Procedure volumes, especially of non-TAVR procedures, are a poor surrogate for TAVR quality.

Consider a successful TAVR program concomitantly performing 330 PCIs yearly. Were this volume to drop, e.g., due to guidelines change and appropriate medical management in 40 patients, does this in any way imply that the TAVR quality would drop? Should the program close, now doing 290 PCIs yearly?

Consider a quality Cath Lab proposing to start a TAVR program, with recruitment of a high-quality TAVR operator, cardiac surgeon and supporting team, but the hospital only performs 250 PCIs yearly. Should this program not be allowed to start and demonstrate what would undoubtedly be excellent TAVR outcomes?

During Covid, Medicare relaxed the NCD requirements, and many new TAVR programs opened. Spoon, D. B., et al. (2024 Mayo Clinic Proceedings 99(8): 1236-1247) showed no difference in outcomes between new and existing programs. Internal data on Medicare patients from Edwards corporation also shows no difference between TAVR outcomes in established and new programs during the COVID era, even though no procedural volume requirements were enforced.

In summary, we propose elimination of PCI volume criteria from the TAVR NCD, and instead, replacement of this flawed surrogate for quality with the direct measurement of TAVR outcomes serving as the criteria to start and maintain a TAVR program.

Drs. Peter Pelikan, Michael Broukhim and Rishi Kaushal, Providence Coastal Cardiology, Los Angeles, California

Less

TAVR has become the gold standard in most AVR for aortic stenosis. It has evolved both procedural and has established an evidence base that nearly no cardiac interventions have. It should be available and performed with the least restrictions to ensure access.

1. Single operator procedure (akin to PCI, TTEER, MTEER, TTVR). This will reduce the need for reimbursement given less need for staffing
2. No evaluation by multiple providers - this should be streamlined so that the patient can meet the interventional cardiologist and have it performed rapidly. If the patient is not anatomically suitable for TAVR he can then be referred for SAVR. This limits costs of multiple consults and removes barriers
3. No requirement for national database - it has simply moved beyond needing a national database, there is little value and adds administrative cost.
4. Would favor implementing these broadly and reducing the reimbursement by the amount required to administer these programs. What drives costs in the US is unnecessary administrative burden for what is an incredibly straight forward procedure.

Less

Dear FDA,

I am a rank and file cardiac surgeon in a rural practice. I have been fortunately enough to be a TAVR provider since the nascence in 2011, and have grown up with the technology. It has been revolutionary on many prospective. It has been a great journey, but also a healthy one. The team component has especially been beneficial. That can not be disrupted. Further I am hesitant about all three requests.

1. Evidence supporting TAVR in asymptomatic patients is limited and based on a single industry-sponsored trial. We should not be treating just the number but looking at valve velocity. The patient and their clinical concerns still needs to remain the focus,
2. Removing registry requirements makes it difficult to track outcomes and maintain quality oversight.
3. While efficiency and access can be improved, I believe surgical involvement remains critical for patient safety—complications still occur. The valve team discussion and management of patient I also strongly feel has lead to better decisions, and better patient care. That can not be done if multiple providers don't meet the pt. This further translated to the procedural execution. Both Interventional Cardiology and Cardiac surgery are qualified. This request should not fall apart into a "turf war." FDA should continue to encourage the collaboration and team intervention for this group of patients.

Thank you

Less

I appreciate the opportunity to provide public comment regarding the current review of the National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR). As a practicing cardiologist with extensive experience caring for patients with valvular heart disease, I would like to comment specifically on the continued requirement for mandatory surgical consultation prior to TAVR.

At the time the original NCD was developed, the requirement for evaluation by both an interventional cardiologist and a cardiothoracic surgeon reflected the early evolution of TAVR and appropriate caution during its initial adoption. However, the field has matured substantially. TAVR is now a well-established therapy across a broad range of surgical risk profiles, with outcomes that are predictable and durable in appropriately selected patients.

Requiring a formal surgical consultation prior to TAVR is increasingly outdated and inconsistent with contemporary practice. Importantly, when a cardiothoracic surgeon independently decides to perform an isolated surgical aortic valve replacement, there is no reciprocal requirement for consultation with an interventional cardiologist who performs TAVR. From a policy and clinical perspective, this asymmetry is difficult to justify. In both cases, experienced specialists are making informed, patient-centered decisions within their own scope of practice.

A more reasonable and modern approach would emphasize an intra-disciplinary framework rather than a rigid, mandated inter-disciplinary consultation. Cardiothoracic surgeons managing isolated aortic valve disease should be empowered to determine when surgical therapy is most appropriate, just as interventional cardiologists should be empowered to determine when transcatheter therapy is optimal. Multidisciplinary collaboration should remain encouraged, but not required as a condition of coverage in every case.

Additionally, I believe the field has reached a point where a single-operator model for TAVR is often optimal. In real-world practice, coordinating schedules between a busy cardiothoracic surgeon and an interventional cardiologist can introduce unnecessary delays in care. These delays may adversely affect patient outcomes, particularly in symptomatic patients with severe aortic stenosis. Allowing a single, appropriately trained and credentialed operator to perform TAVR would improve efficiency, reduce delays, and better reflect how high-quality care is currently delivered in many centers.

In summary, I respectfully recommend that CMS reconsider the requirement for mandatory pre-procedural surgical consultation in the TAVR NCD and consider policy language that supports intra-disciplinary decision-making and permits a single-operator procedural model when clinically appropriate. Such updates would better align the NCD with contemporary evidence, current practice patterns, and the overarching goal of timely, patient-centered care.

Thank you for the opportunity to comment and for your continued efforts to ensure that Medicare coverage policies evolve alongside advances in cardiovascular care.

Sincerely,

Augustin J. Delago, MD
Cardiology
Capital Cardiology Associates
7 Southwoods Blvd
Albany, NY 12211
Phone: 518-292-6000
Fax: 518-292-6050

Less

The current requirement for a mandatory surgical consultation in all TAVR candidates places a significant and often unnecessary burden on a population that is predominantly elderly and medically fragile. Most patients are in their 70s or 80s and already undergo an extensive pre-procedural evaluation that includes a transthoracic echocardiogram, CT TAVR planning, invasive coronary angiography, and consultation with an interventional cardiologist. Adding a separate surgical consult on top of this frequently results in five different appointments, some consultative and others diagnostic or procedural, which for a frail elderly patient often means an entire day devoted to a single study or visit, prolonged time in waiting rooms, repeated transportation arrangements, reliance on family or caregivers to take time off work, and significant physical and cognitive exhaustion by the end of the day. From a practical standpoint, the requirement for two physicians to be physically present during TAVR can be inefficient and may introduce procedural delays without improving safety, particularly in experienced, high volume programs. The vast majority of TAVR related complications can be managed or at least temporized percutaneously, and mandatory coordination among two physicians, anesthesia, and multiple pre-procedure consultations often leads to delays in care for patients with severe symptomatic aortic stenosis, a condition with known high short-term mortality when treatment is deferred. Multidisciplinary decision making already occurs through structured heart team review and does not require duplicative in person surgical consultations for every patient. For these reasons, I strongly support single operator TAVR and the elimination of the mandatory surgical consultation requirement to reduce unnecessary burden, avoid delays in care, and improve timely access to a life-saving therapy.

Less

Appreciate the comments thus far. As a cardiac surgeon with decades of transcatheter and endovascular experience, I also believe that TAVR has become mostly a single-operator procedure given the experience and advancements in the technology. Due to careful preplanning, BOTH coronary obstruction and annular rupture are uncommon. An unbiased multidisciplinary approach is still the key to optimal patient management, including the opinion of both a surgeon and a cardiologist. The procedure itself can be done by a single operator who possesses the skill set to accomplish the procedure. This operator can and should be a surgeon OR a cardiologist. In some settings (ie: rural), it may be more appropriate for a surgeon to do the procedure, in others, a cardiologist. Most of the time, TAVR’s are scheduled procedures, therefore operator or surgeon availability should not be a factor.

A separate issue I would hope CMS would address is reimbursement for outpatient TAVR, or 23 hr observation in selected cases. Thank you for allowing this forum for public comment.

Less

I respectfully submit the following comment to support a coverage approach that preserves beneficiary access while aligning national policy with clinical generalizability, durability, and system sustainability.

1. Coverage policy functions as a de facto guideline
FDA labeling establishes what may be offered. Medicare coverage establishes what becomes routine. The current National Coverage Analysis appropriately acknowledges this distinction by explicitly focusing on patient characteristics that modify benefit and on treatment conditions required to achieve outcomes observed in clinical studies.² For asymptomatic populations, this framing is essential. Coverage expansion without explicit conditions risks transforming a selective intervention into a default pathway, independent of physiologic timing or long-term consequence. CMS coverage policy therefore carries guideline-level influence and warrants equivalent evidentiary discipline.

2. Clinical evidence and strategy-trial interpretation
The FDA expanded labeling for the Edwards SAPIEN 3 TAVR platform to include asymptomatic severe aortic stenosis in May 2025, supported by the EARLY TAVR trial.^1,4 In this study, 901 patients with asymptomatic severe aortic stenosis and preserved left ventricular ejection fraction were randomized to early balloon-expandable TAVR or clinical surveillance, with treadmill stress testing used to confirm asymptomatic status in most participants.³ The primary composite endpoint favored early intervention, driven largely by unplanned cardiovascular hospitalizations.³ Mortality remained similar between groups through the reported follow-up period.³ Interpretation of these findings benefits from careful attention to the strategy design. In asymptomatic populations, hospitalization-inclusive composite endpoints capture care pathways, escalation thresholds, and surveillance intensity in addition to disease progression. CMS’s stated intent to evaluate patient characteristics and treatment conditions directly addresses these interpretive realities and aligns with responsible policy development.

3. Generalizability and patient selection
EARLY TAVR incorporated structured confirmation of asymptomatic status using stress testing in a high proportion of participants.³ Real-world practice varies in access to standardized protocols, interpretation consistency, and follow-up intensity. Coverage policy for an asymptomatic population benefits from explicit criteria that support reproducibility across diverse clinical settings. CMS may wish to consider policy language clarifying evidentiary expectations for confirming asymptomatic status and identifying subgroups most likely to benefit, consistent with the scope described in the National Coverage Analysis tracking sheet.²

4. Durability, reintervention pathways, and longitudinal exposure
Earlier intervention extends the horizon for structural valve deterioration, pacing exposure, coronary access complexity, and downstream reintervention. These considerations influence both patient outcomes and Medicare spending trajectories. As coverage expansion can influence referral patterns and program growth, maintaining longitudinal evidence expectations for asymptomatic indications remains prudent until durability and reintervention data mature.

5. Health-economic modeling and budget impact
Coverage expansion into asymptomatic severe aortic stenosis carries material budget impact. Lifetime cost-effectiveness modeling relies on Markov frameworks and Monte Carlo simulation to propagate uncertainty across durability assumptions, reintervention timing, event rates, utilities, and costs. CMS may wish to consider whether submitted economic analyses include scenario testing across plausible durability curves, explicit reintervention pathways, and national budget impact projections. Such transparency supports policy decisions that balance access with system sustainability.

6. Coverage with evidence development and guardrails
CMS currently covers TAVR under NCD 20.32 with Coverage with Evidence Development requirements, including registry participation.² In the context of asymptomatic severe aortic stenosis, CMS could consider a refined approach that preserves beneficiary access while ensuring that outcomes, utilization patterns, and durability remain measurable and transparent. Options include coverage criteria incorporating standardized patient selection documentation, shared decision-making tailored to asymptomatic risk tradeoffs, registry-based follow-up for asymptomatic cohorts, and periodic reassessment of coverage criteria as longer-term evidence becomes available.

Conclusion
Thank you for initiating a National Coverage Analysis that explicitly asks which patients benefit and which treatment conditions support reproducible outcomes.² A coverage policy that pairs access with guardrails and longitudinal evidence expectations can support patient welfare, clinical credibility, and Medicare sustainability simultaneously.

Respectfully submitted,
Jaishankar Kutty, PhD
Vice President, Regulatory Affairs, Reimbursement and Market Access, RQM+

References
1. Edwards Lifesciences. Edwards TAVR receives FDA approval for patients with asymptomatic severe aortic stenosis. May 1, 2025.
2. Centers for Medicare and Medicaid Services. National Coverage Analysis Tracking Sheet: Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2). Published December 15, 2025.
3. Yao X, Bakhshi H, Roy S. No such thing as too early for TAVI in asymptomatic severe aortic stenosis. American College of Cardiology. February 18, 2025.
4. Généreux P, Schwartz A, Oldemeyer JB, et al. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med. 2025;392:217–227.

Less

TAVR has matured significantly since its introduction, with improvements in device technology, operator experience, procedural efficiency, and safety. The evidence base supporting TAVR is now extensive, including long-term durability data through 10 years and outcomes across all surgical risk categories. More recently, the EARLY TAVR trial published in the New England Journal of Medicine demonstrated that patients with asymptomatic severe AS benefit from early intervention rather than watchful waiting, with significant reductions in death, stroke, and cardiovascular hospitalization. The finding is consistent with earlier randomized trials (RECOVERY, AVATAR) and reflects what many of us observe clinically. Disease progression in AS is unpredictable, and a substantial proportion of patients under clinical surveillance develop acute decompensation that carries a higher procedural risk. The coverage policy should be updated to reflect this evidence and allow treatment of severe AS regardless of symptomatic status.

Despite these advances, significant barriers to timely TAVR remain. In my practice, I routinely see patients with severe AS who experience delays in accessing treatment due to scheduling constraints and regulatory requirements. Published data confirm that TAVR patients wait substantially longer for treatment than SAVR patients, and these delays have real consequences, including increased mortality, higher rates of heart failure hospitalization, and excess healthcare costs. The ACC/AHA have established quality measures targeting treatment within 90 days of diagnosis, yet current barriers make achieving this standard difficult for many patients.

One significant barrier is the requirement for both a cardiac surgeon and interventional cardiologist to be present during TAVR. While this made sense during the early adoption of TAVR, contemporary data demonstrate that procedural safety is now excellent. Conversion to open surgery occurs in fewer than 0.5% of cases in the STS/ACC TVT Registry. It is comparable to or lower than conversion rates during PCI, which does not require dual-operator presence. At many centers, scheduling both operators creates backlogs that delay patient care and is especially challenging for urgent cases. During the COVID-19 pandemic, CMS had leniency with this requirement, and outcomes remained excellent, demonstrating that the strict two-operator mandate is no longer necessary for patient safety. Notably, no other minimally invasive structural heart procedures require two operators, creating inconsistency within current policy.

Additionally, the Coverage with Evidence Development requirements have been satisfied. The TVT Registry has accumulated data on over 500,000 procedures with outcomes comparable to pivotal trials. Long-term durability has been demonstrated. A 30-day composite performance measure endorsed by the National Quality Forum enables direct quality assessment. The original CED questions have been answered, and the continued CED requirements are no longer justified.

I would strongly urge CMS to:
(1) update the NCD to cover treatment of severe AS regardless of symptomatic status, consistent with the EARLY TAVR evidence
(2) change the procedural requirement from two operators to one, allowing an experienced cardiac surgeon or interventional cardiologist to perform TAVR independently while still permitting centers to maintain two-operator systems if they choose
(3) sunset the CED requirements given the extensive evidence now available.

The abovr changes would improve efficiency, reduce patient backlog, and ensure Medicare beneficiaries have timely access to this proven therapy.

Less

Due to the stringent requirements of surgical consultation and presence during percutaneous access TAVR, there are significant delays in patient access to this lifesaving procedure. While we strongly support the role of surgical risk stratification and consultation for cases of clear surgical advantage, the obligatory role in consultation and case support are a bottleneck in the ability to deliver timely and efficient care to a population that would clearly benefit from timely intervention. I believe the process would benefit from some compromise in the need for upstream surgical consultation in certain risk groups where TAVR is clearly the preferred strategy ( >75, prior CABG, valve in valve, STS>6-8%, hostile chest, etc) and removal of the requirement for intraprocedural surgical presence for routine percutaneous transfemoral cases.

Less

Requiring patients to see both a CT Surgeon and an Interventional Cardiologist pre-procedure as well as to have both specialties be present during valve deployment results in delays in care for both TAVR patients and other patients who need to see either of the specialties. There should be a continued multidisciplinary meeting where both are present to advise on each patient. If there needs to be a second opinion or second provider in the procedure it would improve access to allow for a second provider of the same discipline to improve access and scheduling of these critically ill patients.

Less

TAVR has evolved considerably. The procedure now has a <0.2% conversion to open chest surgery. The 7 year low risk Edwards randomized data and 10 year low risk Medtronic randomized data indicate a durable technology that is equivalent or more effective compared to open chest surgery. There is no longer a good reason for all TAVR patients to be first be seen by a surgeon. This increases cost and SIGNIFICANLY delays care, It has been well established that delays in getting AVR result in more heart failure hospitalizations and increased risk of sudden death.

Additionally, the TAVR procedure has become a one operator procedure in most cases. If an operator is more comfortable with two operators, there is no reason the second operator needs to be specifically a surgeon or an interventional cardiologist. Our current requirement of performing the TAVR procedure with an interventionalist and a surgeon CONSIDERABLY delays cases which has caused serious patient harm and even death.

Therefore, I strongly recommend the requirement to see a surgeon in consult and for a surgeon and an interventionalist work together be dropped.

Note that in no other structural valve cases (mitral or tricuspid) is a surgeon AND an interventionist required to be present.

Less

TAVR has evolved tremendously over the past 18 years in the US- the device technology has improved; the operators have become more experienced, the procedure more streamlined and much safer, and the data demonstrating the effectiveness of TAVR is now quite robust. Although the majority of seminal TAVR randomized trials focused on symptomatic patients with AS, we now also have randomized trial data (EARLY TAVR Trial) showing that patients with severe AS who are asymptomatic benefit from early TAVR rather than a traditional ‘watchful waiting’ approach. The goal of care with AS patients therefore should be focused on preventing the inevitable morbidity and mortality associated with progression of the disease- and this means prompt treatment once the diagnosis of severe AS is made.

Despite all of the advances made with TAVR over the past 18 years, significant obstacles to getting patients treated in a timely fashion remain. Recently, my colleagues and I published a study demonstrating that patients undergoing TAVR typically wait 65 days longer for treatment than those undergoing SAVR (even after adjusting for patient characteristics) and that this delay is attributable to imaging testing and the increased number of visits required with cardiac specialists (article in press). Thus, although TAVR and SAVR show clinical equipoise, TAVR requires additional visits with both a cardiac surgeon and an interventional cardiologist prior to treatment, whereas SAVR only requires a cardiac surgeon visit and fewer imaging tests. We also know that these delays are not merely inconvenient for patients- they have serious consequences for both patients and the financial wellbeing of our healthcare system. In this regard, my colleagues and I recently published a study demonstrating that delayed TAVR beyond 90 days of diagnosis increases 3-year mortality risk by 50%, is associated with a 59% increase in the likelihood of heart failure hospitalization, and is associated with $36,740 of excess health care costs (article in press). Thus, there is a clear and urgent need to improve TAVR efficiency in the US.

One significant way that efficiency could be improved would be to reduce the number of operators required to perform the TAVR procedure. Scheduling of TAVR procedures is more difficult than scheduling SAVR at most centers because currently both a cardiac surgeon and an interventional cardiologist are required to participate in the TAVR procedure- thus both physician schedules must align. In many rural and suburban hospitals there is often only one cardiac surgeon and one interventional cardiologist that are trained to do TAVR on staff- and these individuals often provide coverage at multiple hospitals. Thus, the strict requirement for 2 operators introduces scheduling challenges that are very real and lead to a backlog of patients waiting for necessary care. While elective cases may have a set day that both operators are available for TAVR procedures, there are also frequent emergent cases that come through the ER or that are transferred in that require urgent TAVR- and the scheduling of these procedures is even more challenging due to the strict 2 operator requirement. While the requirement for 2 operators to participate in the TAVR procedure certainly made sense in the early days of TAVR, contemporary TAVR data demonstrates that procedural safety has become incredibly good- with conversion to open surgery in the STS database at 0.2%, coronary obstruction at 0.1%, and annular rupture at 0.2%. Of note, these rates are lower than published conversion rates to urgent CABG during PCI procedures (which do not require 2 operators). In addition, during the COVID pandemic it was recognized that the 2 operator requirement may not be able to be met, and thus an emergency waiver was made and TAVR was still successfully performed during this period with excellent outcomes. And finally, it is important to point out that no other minimally invasive structural heart procedures currently require 2 operators to participate, thus there is academic inconsistency within the current policy. Many centers currently choose to perform structural heart procedures with more than one operator, but importantly it is not strictly required.

I would therefore strongly urge CMS to change the current TAVR procedural requirement of 2 operators (specifically requiring a cardiac surgeon and an interventional cardiologist to participate) to only require 1 operator. This would allow for an experienced cardiac surgeon or an experienced interventional cardiologist to perform TAVR as a single operator. Making this change would still allow centers that choose to maintain a 2 operator system to do so, but would allow others the scheduling flexibility necessary to improve efficiency and eliminate patient backlog. Additionally, I would strongly urge CMS to formally cover the treatment of severe asymptomatic AS in the NCD given what we know about the progressive nature of this disease and the favorable data from the randomized EARLY TAVR Trial.

Less

I'm a practicing interventional cardiologist and structural heart physician in Boise, ID which serves a large population of rural and underserved patients across eastern Oregon, Idaho and beyond. My practice is mostly structural heart and I perform approximately 200 TAVR per year. We have only 2 cardiac surgeons in our health system who perform approximately 600 pumps per year and function as co-surgeons for TAVR. Prior to the PHE for COVID we had to shut down our TAVR program due to limited availability of cardiac surgeons (we had only one at the time) for both the pre-procedural visit and the co-surgeon requirement (both mandated in the NCD) which severely limited access to this life-saving therapy for a large percentage of rural and underserved patients and directly resulted in adverse outcomes for the patients we serve. After the PHE which allowed my partner who is an interventional cardiologist and I to perform both the pre-procedural visits and co-surgeon on TAVR cases our volume and outcomes improved significantly and we were able to provide much needed care to the patients we serve. After the PHE was removed we had to hire a surgeon to help with TAVR and we are currently a three-star program performing over 200 TAVR per year but have reached our capacity to treat patients as a direct result of the limited availability of our existing surgeons and our referral to implant time is well beyond safety margins for avoiding untoward outcomes for our patients. The requirement for cardiac surgery to consult on patients prior to TAVR and act as co-surgeon for every procedure is an outdated and onerous requirement that directly results in treatment delays and adverse outcomes. Moreover, it has been published the pre- and post- PHE the outcomes for TAVR were unchanged. While the heart team has a role in decision-making for complex patients where either surgery or TAVR may be considered there should not be a requirement in the NCD that dictates practice and in light of varying access to cardiac surgeons the stipulation limits care in underserved areas like Idaho which ranks number 50 in the country for physicians per capita. I implore you to reconsider the NCD and omit the stipulations for pre-procedural consultation and intra-procedural co-surgeon requirement for this established therapy that has now been proven as a single operator procedure. There are thousands of lives at stake regarding this decision and as this therapy grows which it is anticipated to double in the coming 10 years we will not be able to treat all the patients we serve if these onerous requirements are continued.

Less

Hi. I believe the current iteration of joint participation to be outdated, given the changes to Tavr over the years. The safety and risk spectra of Tavr has changed over the last decade as can be seen in the data presented in tvt registry. Despite this, the mortality of high risk tavr complications in which open surgical conversion has occurred remains exceptionally high, thus negating the benefit of a cardiac surgeon scrubbed and prepped in the procedure for unforeseen emergencies. I do believe there is a significant proportion of Tavrs that require both surgical and Ic participation (including alternate access procedures, complex vascular access or anatomies, or various other high risk cases), but the majority of standard transfemoral tavrs likely does not require both cts and ic to be present. A less restrictive approach would expand access to care and decrease bottlenecks related to cts availability to allow shorter times to therapy and potentially improve outcomes. Given that tavr has a broad risk spectra, and that various programs have different personnel and skillsets available, I would kindly ask for a revision of joint participation to include any combination of one or two interventional cardiologists, one or two cardiac surgeons or a mixture of an interventional cardiologist and cardiac surgeon as patient risk, local skills and availability dictates.

I also believe that it is imperative for patients to still be exposed to ic and cts in the evaluation period and involvement of the heart team and thus recommend the evaluation continue to involve both cts and ic to help present appropriate options to a patient as a team.

Less

The requirement for both an IC and CTS as co-surgeons during TAVR is outdated. TAVR should be a single-operator procedure (either IC or CTS). The current conversion to open heart surgery during cases is <0.5%, comparable to a PCI. Most CTS are minimally involved in the technical aspects of TAVR. CTS should be available only for back-up. In selected complex cases, e.g. need for cut-down for vascular access or cases at high-risk of surgical conversion, a two-operators (IC and CTS) co-surgeons approach may still apply based on local clinical decision-making and judgment.

Finally TAVR operator volume impacts on clinical outcomes; therefore only operators with a certain volume requirement should be allow to perform TAVRs at each center.

Less